Ref. SOP No. QAG/2/033

PHARMEVO (PVT.) LTD.

Document No. QAG/5/088

Title: New Change Management Log Book - Pharma


 
 CRF NoCRF Receiving DateDepartmentTypeCategoryTitle of ChangeExisting SituationProposed ChangeRA NoProposed Change StatusIntended Date Of Impl.Completion StatusCategory AreaActionsActionsTrackingTimelinesCreated OnUpdated OnCreated ByUpdated By
CMP-0001-2402/01/2024PDPermanent Major New Product Launch in Pharmevo Premises Securin 2.5mg Tablet and relaunch of Securin 5mg and Securin 10mg TabletProduct development activities of Securin 2.5mg has been completed.It is proposed to commercialize the Securin 2.5mg tablet.RA-0001-24Approved 31/05/2024ClosedPharma1) PD trial required with stability report PD 2) Technology transfer protocol and cleanability report required PD 3) Registration letter is required RA 4) Availability of Raw material codes SCM 5) Availability of packaging material codes QC(pkg) 6) Approved artwork developed with specification. QC(pkg) 7) Analytical testing method will prepare and update on LIMS QC 8) Method Verification will perform QC 9) Batch document will prepare QA 10) planning of product lunch for commercial SCM 11) process validation will perform QA (val) 12) product will charge on stability QC All action plans executed 1) received 2) received 3) received 4) done 5) done 6) completed 7) done 8) doner 9) prepared 10) Done 11) PV completed 12) product charge on stability. 1) Jan 24 2) Feb 24 3) Jan 24 4) Jan24 5) jan24 6) jan24 7) feb24 8) mar24 9) feb24 10) feb24-march24 11) may 24 12) may24 02/01/202410/05/2024Hafsa FatimaHafsa Fatima
CMP-0002-2402/01/2024International Business Permanent Major Shelf -life | 36 months | Iraqwe are supplying below mentioned produvts in Iraq with 24 months shelf-life 1) Inosita plus XR Tablet 50/1000mg 2) Inosita plus XR Tablet 100/1000mg 3) Erli tablet 25mg 4) Erli plus XR Tablet 12.5mg/1000mgwe will supply above mentioned products with 36months shelf-life.as soon as 36 months stability complete of following products. 1) Inosita plus XR Tablet 50/1000mg 2) Inosita plus XR Tablet 100/1000mg 3) Erli tablet 25mg 4) Erli plus XR Tablet 12.5mg/1000mgN/AApproved 31/08/2024OpenedPharma1.Stability data of 36 months is required (Inosita plus XR Tablet 50/1000mg) QC 2. Stability data of 36 months is required (Inosita plus XR Tablet 100/1000mg) QC 3.Stability data of 36 months is required (Erli Tablet 25mg) QC 4.Stability data of 36 months is required (Erli plus XR Tablet 12.5/1000mg) QC 5. Shelf-life will be updated on SAP. 6. List of Export product shelf life (Iraq) will be updated 1) Done 2) Done 3) Done 4) Done 5) Done 6) In-progress 1) April-2024 2) April-2024 3) jan-2024 4) April-2024 5) may-2024 6) Sep-2024 02/01/202414/06/2024Hafsa FatimaHafsa Fatima
CMP-0003-2403/01/2024SCMPermanent Major Additional source induction of Empagliflozin we are currently procuring Empagliflozin from M/S Fuxin Long Rui pharmaceutical co ltdwe intend to induct one more source M/s Pharmagene limited Add: Kot Nabi Buksh Wala, 34-Km, Ferozpur road, lahore (Pakistan)N/AApproved 31/12/2025OpenedPharma1) Specification agreement will be signed before approval of the source. 2) QC Sample testing report is required. 3) DMF will arrange. 4) PD Trial on new source is required 5) Trail batch Stability studies report. 6) Valid GMP certificate (Country of origin) is required. 7) Valid DML is required. 8) Supplier Questionnaire form will be developed to receive the required information. 9) Quality agreement is required. 10) Vendor will be audited by QA, SCM will get the audit date from vendor . 11) List of approved supplier/materials will be developed and circulated to all concerns departments.(QA-SMS) 12) Strength with amount of material required for process validation. (QA-VAL)13) Procurement of material to conduct commercial batch manufacturing. (SCM)14) Planning of batches to be taken for process validation on new source 15) Process validation will be performed. (qa-vAL) 16) Stability of product will be charged (qc) source approved vendor list updated 1) Done 2) Done 3. Done 4) Done 5) Done 6) Done 7) Done 8) Done 9) Done 10) feb-2024 11) Feb-2024 12) Feb-2024 13) 06-2025 14) nov-2025 15) dec-25 16) dEC-25 03/01/202425/04/2024Hafsa FatimaHafsa Fatima
CMP-0004-2403/01/2024BDPermanent Major Relaunch of Flowplat (Prasugrel) 5mg and 10mg Tablet in PakistanFlowplat is discontinued from the local marketFlowplat is planned for relaunch in Pakistan. RA-0002-24Approved 28/02/2025CancelledPharma1. PD trial with stability report will be submitted PD 2. Source Approval of Prasugrel is required SCM 3. Technology transfer protocol and cleanibility report required PD 4. Registration letter is required RA 5. Availability of Raw material codes SCM 6. Availability of packaging material codes QC (Pkg) 7. Approved artwork will developed with specifications. QC (Pkg) 8. Analytical testing method will prepared and update on LIMS QC 9. Method Verification will performed QC 10. Batch documents (BDR, BMR, BYS, BPR) will prepare QA 11. updating of product information list QA 12. Planning of product launch for commercial SCM 13. Process validation will perform QA-Val 14. PV batches will charge on stability QC 15. MRP and pack size required from marketing Finance Change control has been closed without implementation. 1) Dec-24 2) Nov-24 3) Dec-24 4) Feb-24 5) Nov-24 6) May-24 7) June-24 8) Feb-25 9) Feb-25 10) Dec--24 11) Feb-24 12) Dec-24 13) Feb-25 14) Feb-25 15) Feb-24 03/01/202407/08/2024Hafsa FatimaHamza Ahmed
CMP-0005-2405/01/2024SCMPermanent Major Additional source induction of sunset yellow W/Swe have approved source for Sunset Yelloe i.e KOEL COLORS, INDIAwe intend to induct one more source provisionally M/S Allied Axiom Chemical Pvt Ltd. located at address: E-68, SITE Phase II, Super High industrial area, Karachi Pakistan.N/AApproved 29/03/2024ClosedPharma1. Specification agreement will be signed before approval of the source. SCM 2. QC sample testing report required QC 3. PD Trial perform on new source is required PD 4. Trial batch stability report required PD 5. valid GMP certificate (country of origin) is required. SCM 6. Valid DML is required. SCM 7. Supplier Questionnaire form will be developed to receive the required information. SCM 8. Quality agreement is required. SCM 9. Vendor will be audited once SCm get the audit date from vendor. QA/SCM 10. List of approved supplier/materials will be developed and circulated to all concerns departments. QA All actions has been completed. 1. done 2. done 3. done 4. jan 24 5. done 6. done 7. done 8. done 9. feb 24 10. march 24 05/01/202425/04/2024Hafsa FatimaHafsa Fatima
CMP-0006-2409/01/2024SCMPermanent MinorChange of coating material in specified finished product. Opadry coating materials are currently being utilized in specified finished products mentioned in attached sheet.we propose to chnage opadry coating materials with specific coatinng materials while quantity will remain same in BOM. Also note that these alternates have been already developed and approved against specific opadry SKUs working sheet attached.N/AApproved 28/02/2025OpenedPharma1)Specification agreement will be signed before approval of the source. SCM 2)QC sample testing report required QC 3)comparative study is required PD 4)PD Trial perform on new source is required PD 5)Trial batch stability report required QC 6)valid GMP certificate (country of origin) is required. Valid DML is required. SCM 7)Supplier Questionnaire form will be developed to receive the required information. SCM 8)Quality agreement is required. SCM 9)List of approved supplier/materials will be developed and circulated to all concerns departments. QA 10)Procurement of material SCM 11) Batch document will be updated 12) Process validation will be performed. Process validation is in progress and batch document will be updated. All other actions has been closed. 1) Done 2) Done 3) Done 4) Done 5) Done 6) Done 7) Done 8) Done 9) May-24 10) Feb-25 11) Feb-25 09/01/202412/01/2024Hafsa FatimaHafsa Fatima
CMP-0007-2410/01/2024Medical Affairs Permanent Major Direction insert revision of Retzole Tablet Old information in, Use in specific population. Geriatric use heading to be added in Use in specific population. N/AApproved 29/02/2024ClosedPharma1. Artwork will be updated QC PKG 2. Revised artwork shared with Mfg. QC PKG Action plan executed 1) feb 2024 2) feb 2024 10/01/202423/02/2024Hafsa FatimaHafsa Fatima
CMP-0008-2410/01/2024Medical Affairs Permanent Major Direction insert revision of Xcept Tablet old information regarding all strengths of Xcept, black box warning and complete warning is whole DI. Multiple DI of different strengths and indication change the whole DI in both national and Internation market. N/AApproved 31/07/2025OpenedPharma1. Development and approval of DI QC (Pkg) 2. Regulatory approval required RA 3. Item codes will be open QC (Pkg) 4. Consumption/ destruction of existing inventory SCM 5. Block old item codes to avoid wrong purchase of the materials QC (Pkg) 6. Availability of new inventory as per the new item code artworks. SCM 7. Revision of SAP BOM, and POI QA 1) artwork developed 1) Aug-2024 2) feb-2025 3) Mar 25 4) Jun 25 5) Jun 25 6) Jun 25 7) Jun 25 10/01/202409/08/2024Hafsa Fatima 
CMP-0009-2411/01/2024SCMPermanent MinorNew Vendor induction for packaging components we are purchasing unit carton, direction insert, labels, catch cover, other secondary packaging materials from different approved suppliers.it is proposed to procure unit carton, direction insert, label, catch cover, other packaging materials also from new supplier M/s Grace Packages (Pvt) Ltd. located at plot # F-10, Phase-2, Site-2, Superhighway, karachi N/AApproved 29/03/2024ClosedPharma1) Supplier questionnaire form required 2) Approved vendor list will be updated 3) Vendor will be audited 4) Supplier will be updated in LIMs after receiving of consignment. 5) Print proof and shade card will be approved. vendor list updated. 1) feb-2024 2) jan-2024 3) march-2024 4) feb-2024 5) feb-2024 11/01/202429/03/2024Hafsa FatimaHafsa Fatima
CMP-0010-2411/01/2024SCMPermanent MinorNew Vendor induction for packaging componentswe are purchasing unit carton, direction insert, labels, catch cover, other secondary packaging materials from different approved suppliers.it is proposed to procure unit carton, direction insert, label, catch cover, other packaging materials also from new supplier M/s Printables located at plot No. 47, sec 23 Korangi industrial area, karachi , Pakistan. N/AApproved 31/07/2024ClosedPharma1) Supplier questionnaire form required 2) Approved vendor list will be updated 3) Vendor will be audited 4) Supplier will be updated in LIMs after receiving of consignment. 5) Print proof and shade card will be approved. Closed without implementation. 1) feb-2024 2) jan-2024 3) march-2024 4) feb-2024 5) july-2024 11/01/202431/07/2024Hafsa FatimaHamza Ahmed
CMP-0011-2416/01/2024SCMPermanent Major Alternate source induction for empty shell hard gelatin capsuleWe are currently procuring empty shell hard gelatin capsule from M/S Gelcaps Pakistan Ltd. Add: A-9, Muhammad Ali Bogra Road., bath island, karachi we intend to induct one more source M/s. health capsule Pakistan Add: P-25, Phase 1-A, shahiawala industrial estate, FIEDMC, Faisalabad RA-0004-24Approved 28/06/2024OpenedPharma1. SAF is required SCM 2. Stability reports are required QC 3. Availability of first consignment from new source SCM 4. Process validation will be performed Validation 5. LIMS specification will be revised QC 6. Vendor list will be updated QA 1.Done 2.done 3.done 4. Extension taken till Dec-2024 5.done 6.Vendor list updated 1) Feb-24 2) march-24 3) march-24 4) june-24 5) march-24 6) May-24 16/01/202403/07/2024Hafsa FatimaHafsa Fatima
CMP-0012-2416/01/2024SCMPermanent MinorSource Activation currently M/s. Merck is an in active source for Hydrochloric acid.we intend to activate M/s Merck KGaA located at Frankfurter strabe 250, 64293 Darmstadt (Germany). for the procurement of hydrochloric acid. N/AApproved 29/02/2024ClosedPharma1. Source approval documents are required as per the check list of required documents SCM 2. HCL code will be opened SCM 3. Approved Vendor list will be updated QA 4) testing method will be developed QC 5) specification will be added on LIMS QC action plans executed 1) feb 2024 2) feb 2024 3) feb 2024 4 )feb 2024 5) feb 2024 16/01/202425/04/2024Hafsa FatimaHafsa Fatima
CMP-0013-2424/01/2024SCMPermanent Major Additional source | colloidal silicon dioxide (Aerosil 200)we are currently procuring colloidal silicon dioxide (Aerosil 200) from M/s. Evorik Deggusa.We intend to induct one more source M/s Hubei Huifu Nanomaterials co ltd. located at No. 66-2, Xiaotong Avenue, Xiaotong district, Yichang city, Hubei province, chinaN/AApproved 30/04/2024ClosedPharma1.Source approval documents are required as per the check list of required documents. SCM 2. approved Vendor list will be updated. QA Action plan executed 1) march 2024 2) march 2024 24/01/202425/04/2024Hafsa FatimaHafsa Fatima
CMP-0014-2424/01/2024SCMPermanent Major Additional source | Magnesium stearate We are currently procuring Magnesium stearate from M/s Peter Greven. we intend to induct one more source M/s Huzhou city linghu Xinwang chemical co ltd. located at No.8, Xiuxi middle road, linghu town, Huzhou, Zhejiang province, china. N/AApproved 30/04/2024ClosedPharma1.Source approval documents are required as per the check list of required documents. 2. approved Vendor list will be updated. Action plans executed 1) march 24 2) march 2024 24/01/202425/04/2024Hafsa FatimaHafsa Fatima
CMP-0015-2425/01/2024Production/Non-CephPermanent MinorInstallation of UPS in Blister Machine Currently, China BM-350 blister machines(A,B,C,D,E). are operating without the installation of UPS equipment.It is proposed to install UPS in the BM-350 Blister machines. N/AApproved 31/07/2024ClosedPharma1) Installation of UPS system in blister machine 2) Qualification of UPS. 1) UPS Installed 2) Done 1) may 24 2) Aug 24 25/01/202409/05/2024Hafsa FatimaHafsa Fatima
CMP-0016-2426/01/2024PDPermanent Major Avsar plus (160/10/12.5) shifting to old formulation using plain valsartan instead of valsartan compacted. Avsar plus (160/10/12.5 mg ) tablet is currently manufactured by using compacted grade valsartan.Valsartan compacted grade is replaced by plain valsartan as per old formulation of Avsar plus (160/10/12.5 mg ) and the process will also remain same.N/AApproved 31/01/2024ClosedPharma1) batch documents will be updated. QA Completed 1) 31-01-24 26/01/202431/01/2024Hafsa FatimaHafsa Fatima
CMP-0017-2401/02/2024MicroPermanent Major Installation of Double door Autoclavecurrently, single door autoclave zirbus 40 is in use Cephalosporin quality control microbiology lab, for sterilization of media and accessories used in sterility testing.it is proposed to install double door autoclave in Cephalosporin quality control microbiology lab, for sterility testing area. Existing autoclave will be used for decontamination of waste RA-0007-24Approved 28/06/2024OpenedPharma 1 URS required of double door autoclave Micro 2 IQ,OQ will be performed QA-Val 3 PQ will be performed QA-Val 3 Development of SOP of double door autoclave Micro 4 Training on SOP Micro 5 Equipment will be part of PM plan ENG 6 SOP of existing autoclave will be revised Micro 1) URS received 2) Extension taken for qualification till sep-24 all other actions will be completed in Oct-24 1) feb 24 2) may 24 3) may 24 3) june 24 4) june 24 5) june 24 6) june 24 01/02/202406/06/2024Hafsa FatimaHafsa Fatima
CMP-0018-2402/02/2024QCPermanent Major Area expansion of cephalosporin QC laboratory The current QC Cephalosporin laboratory is able to accommodate the production capacity. Now it needs to expand to maintain smooth testing operation with increase in production.It is proposed to expand the following areas of the QC Ceph Lab. 1) Wet chemistry 2) change room (separate door for micro lab and wet chemistry lab entrance) existing QA retention room will be converted into stability chamber room. N/AApproved 30/09/2024OpenedPharma1) development of layout ENG 2) civil work and electrical work will be conducted ENG 3) qualification activities as per requirement of area val 4) approval of layout from DRAP RA 5) PQ will be performed to instrument moved to extended area of ceph lab QC 6) SOP of growing and degowning will be receiving QC 7) shifting of retention sample to new retention room QA Extension taken 1) development of layout ENGG( Oct-24) 2) civil work and electrical work will be conducted ENG (Mar-25) 3) qualification activities as per requirement of area val (May-25) 4) approval of layout from DRAP(Nov-24) RA 5) PQ will be performed to instrument moved to extended area of ceph lab QC (May-25) 6) SOP of growing and degowning will be receiving QC (May-25) 7) shifting of retention sample to new retention room . QA(Dec-24) 1) feb24 2) july24 3) sep24 4) submission in march 24 approval in may 24 5) sep24 6) sep24 7) june24 02/02/202405/08/2024Hafsa FatimaHamza Ahmed
CMP-0019-2402/02/2024Production Permanent Major Use of Roller compactor in Sacvin 200mg Tablet Currently, Slugging of sacvin 200mg Tablet performed through compression machine (ZPW-23D) & Crushing of tablets done through fitz mill.It is proposed to perform Slugging of sacvin 200mg tablet through compactor machine along with crushing process.RA-0008-24Approved 28/11/2024OpenedPharma1. Process validation will be performed and process specification of compactor machine will be shared Qa-Val 2. PV batches will charge on stability QC 3. BMR will be revised QA 1) Oct-2024 2) Nov-2024 3) Nov-2024 02/02/202415/02/2024Hafsa FatimaHafsa Fatima
CMP-0020-2412/02/2024Distribution Department Permanent Minorstandardization in SAP product Name Currently the product names in SAP are mentioned in different formats.It is to standardize the product name in SAP using the following format: [Product Name] [Dosage Form] [Strength] [CP/PS] [Pack Size] [Country Name if Exported]N/AApproved 29/03/2024ClosedPharmaproduction description in SAP will be updated. Updated march 2024 12/02/202422/05/2024Hafsa FatimaHafsa Fatima
CMP-0021-2412/02/2024Warehouse Permanent Major Change in unit of material Quinoline yellow unit Material Quinoline yellow having item code 1100000150 has unit of measure in master data as “kg” while issuance unit is “g”1. New material code will be opened for this material with UoM as “g” 2. Inventory of existing code will be transfer to new code. 3. Old code 1100000150 will be blocked. 4. BoMs 13-268, 13-56, 13-68 and 13-82 will revised with new item code 5. MO of above products will be revised with new codes RA-0013-24Approved 30/04/2024OpenedPharma1. BOM will be updated QA 2. Batch Dispensing record (BDR) will be revised QA 3. New material code will be open with UoM in grams WH 4. Inventory of existing code (1100000150) will be transfer to new code. WH 5. 1100000150 will be deleted WH 6. LIMS will update on new item code. Extension till Dec-24 1) april 24 2) april 24 3) april 24 4) april 24 5) april 24 6) april 24 12/02/202402/05/2024Hafsa FatimaHafsa Fatima
CMP-0022-2413/02/2024Regulatory Affairs Permanent Major Incorporation of GTIN in Registered products of NigeriaBelow is the list of registered products in Nigeria marketed without GTIN. 1) Evofix 400mg cap 2) evofix suspension 100/5ml 3) X-plended 5mg tablet 4) X-plended 10mg tablet 5) Avsar Tablet 5/80mg 6) Avsar Tablet 160/10mg 7) Avsar Tablet 160/5 mg 8) Nucard 80mg Tablet 9) Nucard 160mg Tablet Registered products will be marketed with GTIN. N/AApproved 31/05/2024ClosedPharma1. GTIN will be issue QC 2. Bacth packaging record (BPR) will be updating QA 1) GTIN issued 2) Updated 1) feb 2024 2) may 24 13/02/202425/04/2024Hafsa FatimaHafsa Fatima
CMP-0023-2413/02/2024Regulatory Affairs Permanent Major Change in the presentation of pack size of Evofix Capsule 400mg in Nigeria.Evofix capsule 400mg are marketed in Nigeria with pack size of 1x10'schange in the presentation in the pack size of Evofix capsule 400mg to 2x5's N/AApproved 30/04/2024ClosedPharma1) development and approval of artwork. QC-pkg 2) regulatory approval required. RA 3) item code will be opened. QC- Pkg 4) old item code will get inactive. QC-Pkg/SCM 5) BOM will be updated on SAP. QA 6) Existing inventory will be discarded. SCM 1)Done 2)Done 3)Done 1) march 24 2) Aug 24 3) march 24 4) march 24 5) Apr 24 6) May-24 13/02/202420/05/2024Hafsa FatimaHamza Ahmed
CMP-0024-2413/02/2024SCMPermanent Major Additional source induction | Valsartanwe have proposed source of Valsartan M/s. ZHEJIANG TIANYU & ZHEJIANG HUAHAI Pharmaceutical.We intend to induct one more source M/s Second pharma co Ltd, Address: No.33, Weiwu road, Hangzhou Gulf Fine Chemical Zone, Shangyu City, Zhejiang province 312369 PR of China N/AApproved 31/12/2025OpenedPharma1. Technical documents will be submitted to QA SCM 2. Procurement of Material from New source SCM 3. Process validation will be performed QA-VAL 4. Product will charge on stability QC 5) vendor list will be updated after source approval QA 1) Extension taken till nov-24 5) Extension taken till nov-24 1) april 2024 2) feb 2025 3) dec 2025 4) dec 2025 5) april 2024 13/02/202406/05/2024Hafsa FatimaHafsa Fatima
CMP-0025-2413/02/2024SCMPermanent Major Additional source induction | Empagliflozinwe have proposed source of Empagliflozin M/s. Fuxin Long Rui Pharmaceutical Co Ltd. We intend to induct on more source M/s. Jiangxi synergy pharmaceutical co ltd adress: Jiangxi Fengxin Industrial Park, Fengxin 330700, Jiangxi Province, ChinaN/AApproved 31/12/2025OpenedPharma1. Technical documents will be submitted to QA SCM 2. Procurement of Material from New source SCM 3. Process validation will be performed QA-VAL 4. Product will charge on stability QC 5. vendor list will be updated after source approval 1) oct 24 2) feb 25 3) dec 25 4) dec 25 5) oct 24 13/02/202422/02/2024Hafsa FatimaHafsa Fatima
CMP-0026-2414/02/2024Business Development Permanent Major Launch of Tenova Plus Tablet 25mg(30's) in Afghanistan This product is not launch in Afghanistan. It is proposed to launch Tenova Plus Tablet (30's) IN Afghanistan. N/AApproved 31/08/2024ClosedPharma1. Product launch in Afghanistan BD 2. Development and approval of artwork QC PKG 3. Regulatory approval required RA 4. Item code will open for new developed artwork QC PKG 5. FG codes will be opened SCM 6. Specification will be updated QC PKG 7. BOM will create on SAP QA 8. BPR will be prepared QA 9. price list will be updated after submission of MRP from finance 1) Done 2) Done 3) Done 4) Done 5) Done 6) Done 7) Done 8) Done 9) Done 1) March 2024 2) feb 2024 3) Feb-2025 4) feb 2024 5) march 24 6) june 24 7) may 24 8) may 24 9_ may 24 14/02/202417/02/2024Hafsa FatimaHafsa Fatima
CMP-0027-2414/02/2024SCMPermanent Major New source induction for Talcum powder we are currently procuring Talcum Powder from M/s Elite Chemical Add : Off.# 601, 6th floor, Hussain Trade Centre, Off Altaf Hussain road, New Challi, karachi we intend to induct this source M/S B.B Minerals located at plot No. 335/03 & 05, Deh Dih Tappo, sector 31-A, Korangi Industrial Area, Karachi-Pakistan N/AApproved 31/07/2024ClosedPharma1) Technical documents will be submitted of new source 2) Approved Vendor list will be updated. 1) Done 2) Done 1. July-24 2. July-24 14/02/202431/07/2024Hafsa FatimaHafsa Fatima
CMP-0028-2414/02/2024Business Development PermanentMajorLaunch of Utfix capsule (20's) for Tender in BotswanaThe product utfix capsule (Tamsulosin) (20's) is not launch in BotswanaIt is proposed to launch the product in Botswana for Tender business. N/AApproved 28/06/2024ClosedPharma1. Product launch BD 2. Development and approval of artwork QC PKG 3. Regulatory approval required RA 4. Item code will open for new developed artwork QC PKG 5. FG codes will be opened SCM 6. Specification will be updated QC PKG 7. BOM will create on SAP QA 8. BPR will be prepared QA 1) Product launched. 2) artwork developed 3) Done 4) Done 5) Done 6) Done 7) BOM created 8) BPR prepared 1) apr 24 2) feb 24 4) feb 24 5) feb 24 6) jun 24 7) april 24 8) april 24 14/02/202422/05/2024Hafsa FatimaHafsa Fatima
CMP-0029-2414/02/2024Business Development PermanentMajorlaunch of sovelpa 400mg/100mg Tablet (28's) in Mali The product sovelpa 400mg/100mg Tablet (28's) is not launch in Mali It is proposed to launch the product in Mali.N/AApproved 29/03/2024ClosedPharma1. Product launch in Botswana BD 2. Development and approval of artwork QC PKG 3. Regulatory approval required RA 4. Item code will open for new developed artwork QC PKG 5. FG codes will be opened SCM 6. Specification will be updated QC PKG 7. BOM will create on SAP QA 8. BPR will be prepared QA closed without implementation 5) march 24 as per registration 14/02/202426/04/2024Hafsa FatimaHafsa Fatima
CMP-0030-2414/02/2024SCMPermanentminorChange in Material description of material of Klucel LF Currently we have hydroxy propyl cellulose excipient with item description as Brand Name '' Klucel LF''We proposed to change item description from Klucel LF to Klucel LF-Hydroxy propyl cellulose. N/AApproved 31/10/2024ClosedPharma1 Material description will be update on SAP WH 2. Approved vendor list will be updated QA 3) testing method and LIMS specification will be updated as new name QC 1 Material description updated on SAP 2. vendor list updated. 3) Testing method and LIMS has been updated. 1) Feb-24 2) Oct-24 3) June-24 14/02/202406/09/2024Hafsa FatimaHamza Ahmed
CMP-0031-2419/02/2024QAPermanentMinorRevision of batch release certificate via SAP Format of batch release certificate contain the data with product name and code, batch number, batch size, data and time of release and SAP ID UD Name Format of batch release certificate will be revised and certificate contains DML No. DRAP No. Product Code and name, MFG Date, Expiry date, pack size, quantity release, date and time of release and SAP ID UD Name N/AApproved 29/02/2024ClosedPharmaSOP will be updated. SOP revised. Feb-2024 19/02/202429/02/2024Hafsa FatimaHafsa Fatima
CMP-0032-2420/02/2024Production/Non-CephPermanent Major Shifting of products to Roller compactor (Doc: No JN-SOP-LGP-200/75II-01) from compression machine currently, slugging of different batches have been performed through compression machine and crushing of tablet done through fitz mill.it is proposed to performed slugging of different batches through roller compactor along with crushing process. N/AApproved 31/12/2024OpenedPharma1. Process validation will be performed and process specification of compactor machine will be shared Qa-Val 2. PV batches will charge on stability QC 3. BMR will be revised QA 3) Extension taken for BMR revision till Dec-24 1) dec 24 2) dec 24 3) aug 24 20/02/202406/09/2024Hafsa FatimaHamza Ahmed
CMP-0033-2420/02/2024Production/Non-CephPermanent Major Increase in batch size A project of increase batch size has been initiated on the basis of market demand to increase the batch size of 14 products as per attached list to meet the required targets.it is proposed to increase batch size of 14 products as per attached list in order to enhance the productivity and to fulfill the market requirement on time.N/AApproved 30/08/2024OpenedPharma1) Batch documents will update 2) BOM will update on SAP. 3)Planning of products on increase in batch size 4) process validation will be conducted. 5) PV batches will charge on stability. Extension taken on all actions. 1) Dec-24 2) Dec-24 3) Dec-24 4) Dec-25 5) Dec-25 1) Aug-24 2) Aug-24 3) march 24 4) Aug-24 5) Aug-24 20/02/202406/09/2024Hafsa FatimaHamza Ahmed
CMP-0034-2421/02/2024PDPermanent Major New Product Launch Trelagliptin 50mg and 100mg Tablet in Pharmevo Premises product development activities of the following generic have been completed. Trelagliptin 50mg Tablet Trelagliptin 100mg Tablet it is proposed to commercialize the following generic in pharm Evo facility.RA-0010-24Approved 31/12/2024OpenedPharma1. PD trial with stability report will be submitted PD 2. Source Approval of Trelagliptin is required SCM 3. Vendor list will be updated QA 4. Technology transfer protocol and cleanibility report required PD 5. Registration letter is required RA 6. Availability of Raw material codes SCM 7. Availability of packaging material codes QC (Pkg) 8. Approved artwork will developed with specifications. QC (Pkg) 9. Analytical testing method will and testing method verification/validation is required PD 10. Testing method will be developed QC 11. Batch documents (BDR, BMR, BYS, BPR) will prepare QA 12. updating of product information list QA 13.Procurement of raw materials.SCM 14) Procurement of Packaging materials. SCM 15) Planning of product launch for commercial SCM 16. Process validation will perform QA-Val 17. PV batches will charge on stability QC 1) Done 2) Done 3) Done 4) Extension till Nov-24 5) Extension till Oct-24 6) done 7)done 8) Artwork developed extension for specification till jan-25 9) Extension till Nov-24 10) Extension till Nov-24 11) Extension till Nov-24 12) Extension till Dec-24 14) Extension till nov--24 15) Extension till Dec-24 16)Extension till May-25 17)Extension till May-25 1) feb 24 2) jun 24 3) jun 24 4) march 24 5) march24 6) done 7) march24 8) march 24 9) april24 10) march 24 11) aug 24 12) july 24 13) march 24 14) march 24 13) Mar-24 14) Mar-24 15) july 24 16) dec 24 17) dec 24 21/02/202404/04/2024Hafsa FatimaHamza Ahmed
CMP-0035-2421/02/2024SCMPermanent MinorChange in Manufacturer NameWe have approved manufacturer by the name of M/s Ind-Swift laboratories limited It is proposed that manufacturer name has been changed to M/s. synthimed laboratories private limited while the manufacturer site/material will remain same. Supplier code will open in SAP N/AApproved 30/08/2024ClosedPharma1. New supplier Code will be open SCM 2. Existing supplier code will get inactive SCM 3. Vendor list will be updated QA 1) Done 2) Done 3) Done 1) may 2024 2) may 2024 3) august 2024 21/02/202429/08/2024Hafsa FatimaHamza Ahmed
CMP-0036-2421/02/2024Engineering Permanent Minorshifting yearly preventive maintenance from in-house to outsource of LG centrifugal chillercurrently, preventive maintenance was carried out in-house on yearly basis as per scheduled preventive maintenance plan generated through SAP yearly preventive maintenance has been shifted to outsource. N/AApproved 29/02/2024ClosedPharma1. SOP pf Preventive maintenance of Centrifugal chiller will update Engineering 2. Training on SOP will be provided Engineering action plans executed. 1) feb 24 2) feb 24 21/02/202401/03/2024Hafsa FatimaHafsa Fatima
CMP-0037-2423/02/2024SCMPermanent Major Additional source | Nimesulide BP we have approved source of Nimesulide BP M/s Aarti Drugs Ltd & M/s Alka laboratories Pvt LtdWe intend to induct one more source M/s Bajaj healthcare Ltd. Address: Unit-1, N-216,217 & 128, MIDC, Tarapur, Boisar-401 506, Maharashtra, India N/AApproved 27/02/2026ClosedPharma1. Technical documents will be submitted to QA SCM 2. Procurement of Material from New source SCM 3. Process validation will be performed QA-VAL 4. Product will charge on stability QC 5. vendor list will be updated after source approval 1) Extension taken till nov-24 5) Extension taken till nov-24 This change control has been closed without implementation. 1) apr 24 2) dec 25 3) feb 26 4) feb 26 5) march 24 23/02/202421/10/2024Hafsa FatimaHamza Ahmed
CMP-0038-2429/02/2024SCMPermanent MinorNew Vendor induction for packaging componentswe are purchasing master carton, unit carton, direction insert, labels, catch cover, other secondary packaging materials from different approved suppliers. It is proposed to procure master carton, unit carton, direction insert, labels, catch cover, other secondary packaging materials also from M/s. JC Packages located at A-73 & A-77, Sector 6F, Korangi, KarachiN/AApproved 28/06/2024OpenedPharma1) Supplier questionnaire form required 2) Approved vendor list will be updated 3) Vendor will be audited 4) Supplier will be updated in LIMs after receiving of consignment. 5) Print proof and shade card will be approved. Extension has been taken for all actions. 1) Dec-24 2) Dec-24 3) Jan-25 4) Jun-24 5) Jun-25 1) march 24 2) march 24 3) april 24 4) jun 24 5) jun 24 29/02/202401/04/2024Hafsa FatimaHafsa Fatima
CMP-0039-2429/02/2024Engineering Permanent Major Upgradation in layout of non ceph production area to accommodate new machines and to improve GMP compliance.Currently non-ceph pharma is 100% occupied with multiple machines and for addition of new machines, there is no space available to place new production machines. Further few manufacturing cubicals are operating with a comman buffer which are at minimum compliance of GMP standards.To accommodate the machines which will be procured in near future i.e. 02 new blister machines with autocartoners, 01 new coating machine, 01 new blister machine for DPI and other machines, therefore it is required to upgrade the existing non-ceph manufacturing area for the purpose and further to improve the GMP compliance add to PAL/ MAL in few are the areas are operating with common buffers according below suggested changes in the manufacturing pharma and partially in material storage areas in warehouse. 1) 02 new rooms A-MP-BLI-07 and A-MP-BLI-08 to accommodate blister machines adjacent to QA office will be constructed (currently batch coding area) in which BM-350 (B) and BM-350 (C) blister machines that are currently placed in A-MP-BLI-01 and A-MP-BLI-02 will be placed also blister room no 05 will be renamed with Blister W.I.P. 2) Newly arrived both HOONGA blister machines will be placed in A-MP-BLI-01 and A-I\1PBL1- 02 respectively and their auto-cartoners will be placed in line with them in their adjacent packing hall. 3) Room A-MP-BLI-08 where BM-350 (B) will be placed; this room will be maintained on low humidity i.e., <35% for that purpose there will be a buffer created in it (between corridor to blister area). 4) A New AHU will be installed with all ducting and utilities work which will serve in room AMP- BLI-08 and its buffer also dehumidifier which is currently installed and serving in room A-MP-BLI-01 and A-MP-BLI-02 rooms will be relocated and installed with this new AHU. 5) Packing office will be relocated adjacent to QA office with its entrance from packing hall. 6) Batch coding will be relocated adjacent to A-MP-BLI-08 with its entrance from packing hall. 7) Entrance door of staging area will be relocated to accommodate enough space for entrance from packing hall. 8) Cold storage-01 in FG warehouse will be converted into office area and existing change room will be converted to Cold storage-).Enviormental condition of cool room is (8-15). 9) Change room of FG warehouse will be relocated in existing buffer area. 10) New offices of Sr.Manager production and G.M production will be constructed in packing hall area at the back side of existing production office. 11)New blister area dedicated only for DPI products will be constructed with buffer between DPI filling and new blisterroom and WIP and new blisterroom, same AHU serving in DPI area will serve in this new blister area. 12)Existing compression area no.07 (A-MP-COM-07) will be replaced by new coating area with MAL & PAL and their entrance will be from coating corridor. 13) MAL & PAL will be created in existing blending 02 area (A-MP-BLN-02) where double cone blender is located and their entrance will be from solid dosage corridor. 14)New PAL, buffer and sieving area will be created for Granulation-02 (A-MP-GRA-02) area. 15)New PAL will be created for blending 01 (A-MP-BLN-01) area. RA-0012-24Approved 31/12/2024OpenedPharma1) Lay out developed. ENGG 2) submission of layout in DRAP. RA 3) Approval of layout. RA 4) Gantt chart developed for tracking of activities. ENGG 5) Qualification activities will be performed as per requirement of area. QA-VAL 6) Segregated processing area by cordoning off production areas prior to working to prevent contamination. ENGG 7) Segregation of finished product. (Cold room). WH 8) For cold storage thermal mapping to be performed at the time of qualification. QA-VAL 1) Done 2) Done 3) Done 4) Done 5) Dec-24. 6) Done 7) Done 8) Done 1)done 2)done 3)april 24 4) april-24 5) Dec-24 6) Mar-24 7) Mar-24 8) Aug-24 29/02/202417/01/2024Hafsa FatimaHafsa Fatima
CMP-0040-2429/02/2024SCMPermanent Major Additional source | Ticagrelorwe have approved source of Ticagrelor M/s Jiangxi synergy & pharma resource We intend to induct one more source M/s Nantong chanyoo Pharmatech co ltd Address: No.2 Tonghai si road, Yangkou chemical Industrial Park, Rudong coastal economic development zone, Nantong city, China N/AApproved 30/08/2024OpenedPharma1. Technical documents will be submitted to QA SCM 2. Procurement of Material from New source SCM 3. Process validation will be performed QA-VAL 4. Product will charge on stability QC 5. vendor list will be updated after source approval 1) Done 2) Done 5) Done 1) march 24 2) aug 24 3) dec 24 4) dec 24 5) apr 24 29/02/202411/03/2024Hafsa FatimaHafsa Fatima
CMP-0041-2404/03/2024Engineering Permanent Major Relocation of supply air diffusers in liquid manufacturing areaCurrently in non- ceph liquid manufacturing area, supply and return air diffusers are arranged on the same wall so there is a probability of short cycling of air and non-uniform distribution of air in the area.Supply air diffusers will be relocated to new position to improve air distribution in the area.RA-0014-24Approved 31/05/2024ClosedPharma1)Relocation of supply grills. Engg 2) Area qualification will be performed. Validation 3) Viable and non-viable count will be performed. Micro 1)Relocation Done 2) Area Qualification has been performed. 3) Viable and non-viable count has been performed 1) March-24 2) May-24 3) May-24 04/03/202420/05/2024Hafsa FatimaHamza Ahmed
CMP-0042-2404/03/2024Business Development Permanent Major Launch Of New product in IraqThe below products are not launch in Iraq 1) Erlina Plus XR (Empagliflozin + Linagliptin + Metformin) Tablet 25/5/1000mg- 28's 2) Erlina Plus XR (Empagliflozin + Linagliptin + Metformin) Tablet 12.5/2.5/1000mg- 28's 3) Zilfom Tablet (Moxifloxacin) 400mg- 5's These products are planned for launch in Iraq N/AApproved 31/07/2024OpenedPharma1. Product launch in Iraq BD 2. Development and approval of artwork QC PKG 3. Regulatory approval required RA 4. Item code will open for new developed artwork QC PKG 5. FG codes will be opened SCM 6. Specification will be updated QC PKG 7. BOM will create on SAP QA 8. BPR will be prepared QA 1) Extension till dec-2025 2) Done 3) Done 4) Done 5) Done 6) Extension till Dec-24 7) Extension till Sep-25 8) Extension tillSep-25 1) May-24 2) April-24 3) March-24 4) April-24 5) April-24 6) July-24 7) May-24 8) May-24 04/03/202403/06/2024Hafsa FatimaHafsa Fatima
CMP-0043-2404/03/2024Business Development Permanent Major Launch Of New product in BurundiThe below products are not launch in Burundi. 1) Avsar Plus (Valsartan + Amlodipine + HCTZ) tablet 5/160/12.5mg - 28's 2) Avsar Plus (Valsartan + Amlodipine + HCTZ) tablet 10/160/12.5mg - 28's These products are planned for launch in Burundi for Tender business. N/AApproved 31/05/2024ClosedPharma1)FG codes will be opened 2) BOM will create on SAP. 3) Local Stock will be transfer to FG code. 1) Done 2) Done 3) Done 1) March-24 2) May-24 3) May-24 04/03/202412/04/2024Hafsa FatimaHafsa Fatima
CMP-0044-2404/03/2024Business Development Permanent Major Launch of Evojoshanda sachet (30's) in USA the product Evojoshanda sachet (30's) is not launch in USA yet It is proposed to launch this product in USA 1) Existing packaging material (UC & sachet will be used 2) MRP will not be mentioned on the packaging 3) Shipper carton of 50 packs each 4) Distributor's Name i.e ''JDJ IMPORTS LLC'' will be printed through injet on UC N/AApproved 29/03/2024OpenedPharma1)product launch in USA 2) FG Code will be opened 3) BOM will update on SAP 4) BPR will be prepared 5)MC & supplier code open 1) Extension till jan-25 2) Done 3) Done 4) Done 5) Done 1)APR-24 2)MAR-24 3)MAY-24 4)MAY-24 5)MAR-24 04/03/202403/05/2024Hafsa FatimaHafsa Fatima
CMP-0045-2404/03/2024Business Development Permanent Major Launch Of New product in Philippines The product is Rosunav (Rosuvastatin) tablet 10mg (10 x 10's) not launched in Philippines yet. The product Rosunav ( Rosuvastatin) tablet 10mg (10 x 10's) is planned for launch in Philippines. N/AApproved 31/07/2024ClosedPharma1) Product launch in Philippines BD 2. Development and approval of artwork QC PKG 3. Regulatory approval required RA 4. Item code will open for new developed artwork QC PKG 5. FG codes will be opened SCM 6. Specification will be updated QC PKG 7. BOM will create on SAP QA . 8) BPR will be prepared. 1) Product Launched 2) artwork developed 3) Done 4) Done 5) Done 6) Done 7) BOM prepared 8) BPR prepared 9) 1) july 24 2) mar 24 3) april 24 4) mar 24 5) apr 24 6) jul 24 7) july 24 04/03/202412/06/2024Hafsa FatimaHafsa Fatima
CMP-0046-2404/03/2024Business Development Permanent Major Launch Of New product in Azerbaijan The product is mentioned in the attached list are not launch in Azerbaijan These products are planned for launch in Azerbaijan N/AApproved 28/06/2024ClosedPharma1) Development and approval of artwork QC PKG 2. Regulatory approval required RA 3. Item code will open for new developed artwork QC PKG 4. FG codes will be opened SCM 5. Specification will be updated QC PKG 6. BOM will create on SAP QA 7. Product launch BD 8) BPR will be prepared. 1) Done 2) Done 3) Done 4) Done 5) Done 6) Done 7) Done 8) Done 1) march-24 2_ Done 3) March-24 4) march-24 5) June-24 6) May-24 7) May-24-June2024 8) May-2024 04/03/202403/07/2024Hafsa FatimaHafsa Fatima
CMP-0047-2404/03/2024Business Development PermanentMajorLaunch Of New product in MyanmarThe product is not launch in Myanmar Evofix (Cefixime 100mg/5ml suspension 60mlThese products are planned for launch in MyanmarN/Anot Approved31/07/2024ClosedPharma 04/03/202407/03/2024Hafsa FatimaHafsa Fatima
CMP-0048-2405/03/2024Business Development Permanent Major Launch Of Nise (Nimesulide) 100mg Tablet 20's in Afghanistan The product is not launch in Afghanistan. Nise (Nimesulide) 100mg Tablet 20's is planned to launch in Afghanistan. N/AApproved 29/03/2024ClosedPharmaProduct launch in Afghanistan 2. Development and approval of artwork QC PKG 3. Regulatory approval required RA 4. Item code will open for new developed artwork QC PKG 5. FG codes will be opened SCM 6. Specification will be updated QC PKG 7. BOM will create on SAP QA 8. BPR will be prepared QA 1) artwork developed already BOM created on SAP 1) march-24 2) done (Local supplies) 3) approved 4) Done (local supplies) 5) march-24 6) done 7) march-24 8) march-24 05/03/202425/04/2024Hafsa FatimaHafsa Fatima
CMP-0049-2405/03/2024Business Development Permanent Major Launch Of New product in French West AfricaThe product is mentioned in the attached list are not launch in French West Africa.These products are planned for launch in French West Africa.N/AApproved 28/06/2024OpenedPharma1) Development and approval of artwork QC PKG 2. Regulatory approval required RA 3. Item code will open for new developed artwork QC PKG 4. FG codes will be opened SCM 5. Specification will be updated QC PKG 6. BOM will create on SAP QA 7. BPR will be prepared QA 8. Product launch 1) Extension taken till jun-24 (Closed) 2) Done 3) Extension taken till jun-24(Closed) 4)Extension taken till oct-24 5) Extension taken till Mar-25 6)Extension taken till Mar-25 7)Extension taken till Mar-25 8)Extension taken till Mar-25 1) march-24 2) April-24 (Emaglin) May-24 (Inosita) 3) March-24 4) March-24 5) June-24 6) April-24 7) April-24 8) April-24 05/03/202402/05/2024Hafsa FatimaHafsa Fatima
CMP-0050-2405/03/2024Production/Non-CephPermanent Major Addition of new weighing balance (Model: GF-300)Currently, we have procured new weighing balance (Model: GF-300) for capsule filling machine Z-25 for DPI section. It is proposed to add newly procured weighing balance (Model: GF-300) at capsule filling machine Z-25 for DPI section. N/AApproved 31/05/2024ClosedPharma1. Qualification (IQ,OQ,) will be performed QA-Val 2. Allocation of Equipment ID ENG 3. Equipment list will be updated QA-Val 4. PQ will be performed QA-Val 5. SOP will be updated Production 6. Training on SOP will be provided Production 1) IQ, OQ has been performed. 2) Equipment ID allocated. 3) Equipment list will be updated. 4) PQ has performed. 5) SOP has been prepared. 6) Training has been provided 1) May-24 2) March-24 3) June-24 4) May-24 5) May-24 6) May-24 05/03/202431/05/2024Hafsa FatimaHafsa Fatima
CMP-0051-2406/03/2024SCMPermanent Minormerger between two manufacturerswe have approved sources for strawberry Durarome Flavors M/s. Firmenich (California)supplier has notified about their Merger with DSM and now manufacturer name has been changed to DSM-Firmenich. supplier notification letter attached for reference.N/AApproved 31/10/2024ClosedPharmavendor list will be updated. 1) Vendor list has been updated. 1) Oct-24 06/03/202406/09/2024 Hamza Ahmed
CMP-0052-2407/03/2024production/ cephPermanentMinorcezox capsule 400 mg 2-D barcode overprinting of unit Carton.currently in cezox capsule 400 mg overprinting is perform by offline BME printing. it is proposed to initiate the online 2-D barcode overprinting on unit Carton.N/AApproved 29/03/2024ClosedPharma1) GTIN No of the product will be assign 2) batch no. from which change is implemented 1) GTIN No of the product assign 2) batch no. shared 1) March-24 2) May-24 07/03/202403/05/2024Hafsa FatimaHafsa Fatima
CMP-0053-2413/03/2024International Business Permanent Major Transitioning to Linear barcode system In Guatemala, following products old/approved barcode was alraedy registered in the pharmacy chains and we changed the barcodes which pharmacies are not accepting 1) Inosita plus Tab 50/500mg 2) Inosita Plus Tab. 50/1000mg 3) Anex Tab 550mg 4) Gabin Tab 400mg It is proposed to change as per below changes from our next supplies. 1) Inosita plus Tab 50/500mg; replace barcode no. from 8964003194369 to 7401095801726 2) Inosita plus 50/1000mg; replace barcode no from 8964003194376 to 7401095801719 3) Anex 550mg; replace barcode no from 741095800262 to 7401095500408 4) Gabin 400mg; replace barcode no from 8964001420538 to 7401095800194N/AApproved 31/07/2024OpenedPharma1. Developmemnt of artwork QC (Pkg) 2. Codes of new developed artwork will be opened in SAP QC (Pkg) 3. Specifications will be updated QC (Pkg) 4. Block old item codes to avoid wrong purchase of the materials QC (Pkg)/ SCM Write off, immediately switch to revise one 5) Anex 550mg Tab.10's CP (1200001465) Inosita Plus 50/1000 CP (1200002865) Gabin 400mg Tab 30's CP (1200003110) Gabin 400mg Tab 10's CP (1200003111) SCM 6 Availability of new inventory as per the new item code SCM 7 Revision of BOM, BPR QA 8 Issuance of 1st batch No. of the product on which this change will be implemented SCM changed once material consumed or left over less than 3000 uni 9) Inosita Plus 50/500 CP (1200002866) Inosita Plus 50/1000mg 28s (1200002940) Anex 550mg Tab. 30's CP (1200003309) 10. Availability of new inventory as per the new item code SCM 12. Revision of BOM, BPR QA 13. Issuance of 1st batch No. of the product on which this change will be implemented SCM artwork developed codes opened 1) May 24 2) May 24 3) Jul 24 4)Jun 24 5)May 24 6)May 24 7)Aug 24 8)May 24 9)May 24 10)May 24 11) Aug 24 12) Aug 24 13/03/202408/08/2024Hafsa FatimaHafsa Fatima
CMP-0054-2413/03/2024International Business Permanent Major Shelf -life | 36 months | Philippines we are supplying below mentioned products in Philippines with 24 months shelf-life. 1) X-pended Tablet 10mg 2) Avsar Tab 5/80mg 3) Avsar Tab 10/160mgWe have received below products variation approval on 36 months shelf-life. 1) X-pended Tablet 10mg 2) Avsar Tab 5/80mg 3) Avsar Tab 10/160mgN/AApproved 28/06/2024OpenedPharma1)Stability data of 36 months is required X-pended Tablet 10mg 2) Stability data of 36 months is required (Avsar Tab 5/80mg) QC 3) Stability data of 36 months is required (Avsar Tab 10/160mg) QC 4)Registration letter required RA 5. Shelf-life will updated on SAP. WH 6. List of Export product for shelf life will be updated. 1) Done 2) done 3) Done 4) done 5) done 6) Extension till Dec-24 1) march-24 2) march-24 3) march-24 4) march-24 5) JUne-24 13/03/202403/07/2024Hafsa FatimaHafsa Fatima
CMP-0055-2418/03/2024Business Development Permanent Major Launch of New Product in AfghanistanBelow mentioned products are not not launched in Afghanistan yet. 1) AF-D (cholecalciferol 10,000IU) chewable tablet CP (8's) and PS (2's) 2) Anex M (Sumatriptan 85mg + Naproxen 500mg) CP (2's) and PS (2's) 3) Nise (Nimesulide 100mg) Tablet PS 2's 4) Tenova plus (Tenofovir Alafenamide 25mg) Tablet PS 2's These products are planned for launch in Afghanistan. N/AApproved 28/06/2024OpenedPharma1. Product launch in Afghanistan BD 2. Development and approval of artwork QC PKG 3. Regulatory approval required RA 4. Item code will open for new developed artwork QC PKG 5. FG codes will be opened SCM 6. Specification will be updated QC PKG 7. BOM will create on SAP QA 8. BPR will be prepared QA 1) Extension till mar-25 2) Done 3) Done 4) Done 5) Done 6) Done 7) Done 8) Done 1) march 24 2) march 24 3) march 24 4) march 24 5) march 24 6) jun 24 7) april 24 8) april 24 18/03/202402/04/2024Hafsa FatimaHafsa Fatima
CMP-0056-2420/03/2024PDPermanent majorchange in formulation of Dapwiz plus XR tablets (process improvement)Dapwiz plus XR tablets Dapagliflozin layer is being manufactured through dry granulation process and sodium carboxy methyl cellulose (SCMC) is used in metformin HCL layer attached in annexure-1. 1) Dapwiz plus XR tablets 5/500 mg tab 2) Dapwiz plus XR tablets 10/500 mg tab 3) Dapwiz plus XR tablets 5/1000 mg tab 4) Dapwiz plus XR tablets 10/1000 mg tab it nis proposed that dapagliflozin layer will be wet granulation by (iso propyl alcohol) (IPA) and carboxy methyl cellulose (SCMS) in metformin HCL layer will be replaced by polyvinly pyrollidone PVP K-90 plasdone attached in annexure-1 PV report reference 1) Dapwiz plus XR tablets 5/500 mg tab (QAV/PVLR/PHR/043-23) 2) Dapwiz plus XR tablets 10/500 mg tab (QAV/PVLR/PHR/028-23) 3) Dapwiz plus XR tablets 5/1000 mg tab (QAV/PVLR/PHR/027-23) 4) Dapwiz plus XR tablets 10/1000 mg tab (QAV/PVLR/PHR/027-23) RA-0016-24Approved31/12/2024OpenedPharma1. PD trial is required PD 2. Batch documents will be updated QA 3. Process validation will be performed QA-Val 4. PV batches will charge on stability QC 1) submitted 2) Batch documents revised 3) PV in progress 1) Done 2) May-24 3) Dec-24 4) Dec-24 20/03/202425/04/2024Hafsa FatimaHafsa Fatima
CMP-0057-2420/03/2024RApermanentmajorQR code printing on the Tajikistan commercial products. In Tajikistan, QR code (manufacturer name, batch number and shelf life ) is not printed on the packaging of the marketed products. 1) Erli 10 mg 2) Ester 10mg tablet 3) Evofix suspension 100mg- ml 4) Sovelpa tab 5) Tenova plus 25mg 6) Ferfer Gro sachet 7) Ferfer sachet 8) Supercran sachet In Tajikistan, QR code (manufacturer name, batch number and shelf life ) will be printed on the packaging of the marketed products. 1) Erli 10 mg 2) Ester 10mg tablet 3) Evofix suspension 100mg- ml 4) Sovelpa tab 5) Tenova plus 25mg 6) Ferfer Gro sachet 7) Ferfer sachet 8) Supercran sachet N/ANot Approved  ClosedPharma 20/03/202427/03/2024Hafsa FatimaHafsa Fatima
CMP-0058-2427/03/2024Engineering permanentmajorInstallation of SS Exhaust hood in granulation 02, blending 01 and blending 02 currently oscillator granulator is being used in granulation 02, blending 01 and blending 02 along with other equipmentA separate SS exhaust hood will be installed in all three areas to isolate oscillatory granulator from other machines and their respective processes N/AApproved01/10/2024ClosedPharmaInstallation of SS hood. Closed without implementation July-24 27/03/202422/04/2024Hafsa FatimaHafsa Fatima
CMP-0059-2401/04/2024Production/Non-CephPermanent Major Shifting of Compression MachinesCurrently T-700 Compression Machine is placed in Compression cubicle No.2 and ZP37B-I is placed in Compression cubicle No.4 at Production Non-Ceph Building.It is proposed to shift T-700 Compression Machine from compression cubicle No.2 to cubicle No.4 and ZP37B-I compression machine will be shifted from compression cubicle No.4 to cubicle No.2 RA-0018-24Approved 31/07/2024ClosedPharma1)Machine will be shifted. Engg 2)Installation of machine in respective cubicles. Engg/Validation 3)Performance qualification will be performed. Validation 4)Re-calibration of machine will be conducted. validation All actions have been completed. 1) Done. 2) Done 3) PQ has been performed. 4) Re-calibration of machine has been conducted. 1) May-24 2) May-24 3) May-24 4) June-24 01/04/202430/05/2024Hafsa FatimaHamza Ahmed
CMP-0060-2401/04/2024SCMpermanentMinorChange in design and color of Cold Formable Foil for ZI-AD Dispersible Tablet 20mgCurrently Cold Formable Foil (166mm) of Zi-AD Tablet is with old design and color i.e. with PharmEvo logo, “ Our dream, a healthier society” in dark blue color. Manufacturer/ Vendor: M/s. N.J Enterprises, (Plot #33/9, Sector 15, Korangi Industrial Area, Karachi). Note: This product is not commercialized yet. It is proposed to change the existing printing pattern and color of Cold formable foil (166mm) for ZI-AD tablet to the new pattern and color from the same vendor i.e. M/s N.J Enterprises, (Plot #33/9, Sector 15, Korangi Industrial Area, Karachi. All other specs will remain same. Comparision study is attached as annexure I. N/AApproved31/05/2024ClosedPharma1) Specification of CFF will be updated in LIMS for description, design and color. QC(PKG) 2)SAP BOM will be updated. QA 3)Batch packaging record will be updated. QA 1) Specifications has been updated. 2)SAP BOM updated. 3) BPR (Batch Packaging record) updated. 1) May-24 2) May-24 3) May-24 01/04/202420/05/2024Hafsa FatimaHamza Ahmed
CMP-0061-2401/04/2024SCMpermanentMajorAdditional source induction of Vortioxetine HydrobromideWe have approved source for Vortioxetine Hydrobromide as M/s JIANGSU YONGANWe intend to induct one more source M/s Shijazhuang Lonzeal Pharmaceutical Co., ltd No. 16 west ring road, shenze shijiazhuang 052560 chinaN/AApproved25/04/2025OpenedPharma1. Technical documents will be submitted to QA SCM 2. Procurement of Material from New source SCM 3. Process validation will be performed QA-VAL 4. Product will charge on stability QC 5. vendor list will be updated after source approval 1) Done 2) Done 5) Done 1) june-24 2) July-24 3) Oct-24 4) Oct-24 5) Jun-24 01/04/202410/05/2024Hafsa FatimaHafsa Fatima
CMP-0062-2401/04/2024SCMPermanentMajorAdditional source induction of Escitalopram Oxalate.We have approved source for Escitalopram Oxalate as M/s SHODHANA LABORATORIES and Zhejiang Huahai Pharmaceutical Co,LtdWe intend to induct one more source M/s Zhejiang Haisen Pharmaceutical Co., ltd. Xiangtan village , Liushi Street Dongyang city, Zhejiang province, China. N/AApproved30/04/2025OpenedPharma1. Technical documents will be submitted to QA SCM 2. Procurement of Material from New source SCM 3. Process validation will be performed QA-VAL 4. Product will charge on stability QC 5. vendor list will be updated after source approval Technical documents submitted vendor list updated 1) June-24 2) April-25 3)July-25 4) July-25 5) May-24 01/04/202410/05/2024Hafsa FatimaHafsa Fatima
CMP-0063-2402/04/2024PDPermanent Major Addition of New instrument in PD Lab Currently, we have followimng quantity of HPLC, Dissolution tester and other instruments 1) HPLC 2) Dissolution tester 3) PH meter 4) UV Spectrophotometer 5) Ultrasonic bath 6) water bath Now following instrument will be added for testing in PD laboratory. 1) Analytical ablance 2) semi micro balance 3) orbital shaker 4) vortex mixer 5) magnetic stirrer 6) digital hot plate stirrer N/AApproved 31/07/2024OpenedPharma1.Calibration will be performed and list will be updated 2.SOPs of equipments will be prepared and training on SOPs will be provided 3.Equipment list will be updated 4)Installation of qualification of equipment 1) Done 2) Extension till Oct -24 3) Extension till Oct -24 4) Extension till Dec-24 1) July-24 2) July-24 3)July-24 4)July-24 02/04/202405/08/2024Hafsa FatimaHamza Ahmed
CMP-0064-2403/04/2024SCMPermanent MinorAlternate source approval of Tween 80Currently we have availability issue of excipient Tween 80 from our approved source M/s Fisher chemical co. & Seppic International FranceWe proposed to provisionally approve another manufacturer for tween 80 M/s Croda Singapore Pte Ltd Address: 30 Serays Avenue Singapore 627884 to avoid shortage of material for business continuity. Further, utilization of Tween 80 in the products attached N/AApproved 30/04/2025OpenedPharma1) Vendor list will be updated 2) Tween 80 from supplier M/s Fisher chemical co. & Seppic International France will be excluded from list 3) first commercial batch will charge on stability 4) Alternate source will be developed 1) vendor list updated 2) Tween 80 from supplier M/s Fisher chemical co. & Seppic International France excluded from list 1) Apr-24 2)Apr-24 3) Dec-24 4) Apr-25 03/04/202410/05/2024Hafsa FatimaHafsa Fatima
CMP-0065-2408/04/2024SCMPermanentMajorLaunch of Additional pack size of Low plat 75mg Tablets in 30's pack We have DRAP registration of Low plat 75mg tablets in two different pack sizes 10'spacks and 30's packs and only 10's pack has been launched.Now we are going to launch lowplat 75mg tablets in 30's packs.N/AApproved31/07/2024OpenedPharma1. Development and approval of artwork BD 2. Item Code will be opened QC Pkg 3. FG Code will be opened SCM 4. BOM of 30’s pack size will be updated on SAP QA 5. BPR will be revised QA 1) Nov-24 2) Nov-24 3) Oct-24 4) Dec-24 5) Dec-24 08/04/202426/07/2024Hafsa FatimaHamza Ahmed
CMP-0066-2408/04/2024SCMPermanentMajorLaunch of Additional pack size of Lowplat plus 75/75mg and 75/150mg tablets in 30's packs.We have DRAP registration of lowplat 75/75mg and 75/150mg tablets in 2 different pack size 10's packs and 30's packs and only 10's pack have been launched.Now we are going to launch lowplat plus 75/75mg and Lowplat plus 75/150mg tablets in 30's packs.N/AApproved31/07/2024OpenedPharma1. Development and approval of artwork BD 2. Item Code will be opend QC Pkg 3. FG Code will be opened SCM 4. BOM of 30’s pack size will be updated on SAP QA 5. BPR will be revised QA 1) Nov-24 2) Nov-24 3) Oct-24 4) Dec-24 5) Dec-24 08/04/202426/07/2024Hafsa FatimaHamza Ahmed
CMP-0067-2408/04/2024SCMPermanentMajorLaunch of Additional pack size of Xplended 5mg,10mg and 20mg tablets in 30's packs.We have DRAP registration of Xplended 5mg,10mg and 20mg tablets in 2 different pack sizes 10's pack and 30's packs and only 10's packs have been Launched.Now we are going to launch Xplended 5mg,10mg and 20mg tablets in 30's packs.N/AApproved31/07/2024OpenedPharma1. Development and approval of artwork BD 2. Item Code will be opend QC Pkg 3. FG Code will be opened SCM 4. BOM of 30’s pack size will be updated on SAP QA 5. BPR will be revised QA 1) Nov-24 2) Nov-24 3) Oct-24 4) Dec-24 5) Dec-24 08/04/202426/07/2024Hafsa FatimaHamza Ahmed
CMP-0068-2416/04/2024PDTemporaryMajor Addition of compaction process in Diu-Tansin from wet granulation to compaction to improve hardness of tablet in batch # 4C032, 4C064 and 4C065Diu-Tansin (Losartan/Hydrochlothiazide) batches is being manufactured through wet granulation process then proceeded for compression process. product trend for hardness is between 5-8Kg whereas standard limit for hardness is 4-20KgTo improve hardness compaction process will be added after wet granulation before compression process. RA-0019-24un approved30/08/2024ClosedPharmaFirst three batches correction done manually in BMR, PD Process validation will performed QA (VAL) Preparation of batch document (BMR) QA Process validation batches will charge on stability QC (Stability) After successful PV Batch Manufacturing record will be revised PV done product charged on stability March -24 March -24 March -24 August-24 16/04/202425/04/2024Hafsa FatimaHafsa Fatima
CMP-0069-2416/04/2024Production/Non-CephPermanent Major Revision Of LOD limit A project of revise LOD of different batches have been initiated as per nature of APIIt is proposed to revise the limit of LOD in attached list of batches N/AApproved 30/09/2024OpenedPharma1)Batch document will be updated Sep-24 16/04/202425/04/2024Hafsa FatimaHafsa Fatima
CMP-0070-2416/04/2024Business Development Permanent Major Inosita Tablet 50mg (70's) for SPC Tender in SriLankanInosita (Sitagliptin) tablet 50mg is not provided through SPC tender in SriLankan Inosita (Sitagliptin) tablet 50mg will be provided through SPC tender in SriLankan N/AApproved 01/06/2024ClosedPharma1)Launch of product in Srilanka 2) Development and approval of artwork (U/C,) QC 3) Item code will open for new developed artwork QC 4) FG Codes will open in SAP SCM 5) Specification will update QC 6)EPO instruction required 7) .BOM will create on SAP QA 8) BPR will prepare. QA 1)Done 2)Done 3)Done 4)Done 5)Done 6)Done 7)Done 8)done 1)APR-24 2)APR-24 3)APR-24 4)APR-24 5)JUN-24 6)APR-24 7)MAY-24 8)MAY-24 16/04/202424/05/2024Hafsa FatimaHafsa Fatima
CMP-0071-2416/04/2024Business Development Permanent Major Change of Brand Name of Cipromax (Ciprofloxacin) suspension to Evocin suspension in Afghanistan This product is launched in Afghanistan with brand name Cipromax suspension. Brand name will be changed to Evocin suspension. N/AApproved 31/07/2024ClosedPharma1. Development and approval of artwork 2. Communication of approved artwork to NovaMed 3. Forecast of product launch on New brand name 4. Communication of existing inventory utilization 5. Communication of cut-off batch from manufacturer 6. Communication ofg first batch with new brand name from manufacturer Closed without implementation 1) May-24 2) May-24 3) May-24 4) May-24 5) May-24 6) june-july24 16/04/202423/08/2024Hafsa FatimaHamza Ahmed
CMP-0072-2416/04/2024Business Development Permanent Major Launch of Erli plus XR tablet 25mg + 1000mg (28's) in IraqErli plus XR tablet 25mg + 1000mg (28's) is not launch in Iraq yet This product is planned for launch in Iraq N/AApproved 30/08/2024ClosedPharma1. Registration Letter required RA 2. Product launch in Iraq BD 3. Development and approval of artwork QC PKG 4. Regulatory approval required RA 5. Item code will open for new developed artwork QC PKG 6. FG codes will be opened SCM 7. Specification will be updated QC PKG 8. EPO instructions required BD 9. BOM will create on SAP QA 10. BPR will be prepared QA All actions have been completed. 1) Done 2) Done 3) Done 4) Done 5) Done 6) Done 7) Done 8) Done 9) Done 10) Done 1) June-24 2) june-24 3) june-24 4) jun4-4 5) july-24 6) june-24 7) Aug-24 8) may-24 9) june-24 10) july-24 16/04/202423/08/2024Hafsa FatimaHamza Ahmed
CMP-0073-2416/04/2024Business Development Permanent Major launch of VazcareTablet 10mg (10x10's) in Philippines This product is not launch in philippines yet The product Vascare Tablet 10mg (10x10's) is proposed to launch in Philippines. N/AApproved 30/08/2024ClosedPharma1. Registration Letter Required RA 2. Product launch in Philippines BD 3. Development and approval of artwork QC PKG 4. Regulatory approval required RA 5. Item code will open for new developed artwork QC PKG 6. FG codes will be opened SCM 7. Specification will be updated QC PKG 8. EPO instructions required BD 9. BOM will create on SAP QA 10. BPR will be prepared QA All actions have been completed. 1) Done 2) Done 3) Done 4) Done 5) Done 6) Done 7) Done 8) Done 9) Done 10) Done 1)July2024 2)July2024 3)July2024 4)July2024 5)July2024 6)After registration 7)Aug 2024 8)May 2024 9)july2024 10)July2024 16/04/202422/07/2024Hafsa FatimaHamza Ahmed
CMP-0074-2417/04/2024SCMPermanent Major Addition of Supplier for approved manufacturer Tablettose 80 is being imported by M/s MEGGLE GmbH & Co. KG directly with manufacturing site located at Megglestr 6-12, 83512 WASSERBURG, Germany Tablettose 80 to be procured locally from the local supplier of M/S MEGGLE GmbH & Co. KG ie M/s Pharma Chemicals located at house # 60 block 7/8 DMCHS Tipu Sultan Road karachi oakistan N/AApproved 31/05/2024ClosedPharma1)Vendor list will be updated vendor list updated 1)May 2024 17/04/202410/05/2024Hafsa FatimaHafsa Fatima
CMP-0075-2417/04/2024Production/CephPermanent MinorInclusion of weight adjustment reconciliation in BMRCurrently weight adjustment reconciliation is not in BMRInclusion of weight adjustment reconciliation in BMR (List of Products attached)RA-0022-24Approved 31/12/2024OpenedPharma1) Batch documents will be revised In progress Nov 24 17/04/202425/04/2024Hafsa FatimaHafsa Fatima
CMP-0076-2417/04/2024International Business Permanent Major Shelf Life Extension (Srilanka)We are supplying below mentioned products in Sri Lanka with 24 months shelf life: 1. Ibandro 150mg 2. Inosita 50mgWe have received below products' variation approval on 36 months shelf life. We will supply the same from next consignment: 1. lbandro 150mg 2. lnosita 50mgN/AApproved 31/07/2024OpenedPharma1)Stability data of 36 months is required Ibandro 150mg 2) Stability data of 36 months is required Inosita 50mgQC 3)Registration letter required RA 4. Shelf-life will updated on SAP. WH 5) Export product list will be updated 1) Done 2) Done 3) Timelines extension till Nov-24 4) Timelines extension till Dec-24 5) Timelines extension till Dec-24May 2024 May 2024 April 2024 May 2024 July 2024 17/04/202409/05/2024Hafsa FatimaHafsa Fatima
CMP-0077-2417/04/2024Production PermanentMajorInstallation of new Hoonga Blister Machine (Auto-Cartoner) The Products mentioned on the attached list are currently being blistered on BM-350 as per mentioned dimensions(list attached). A/FOIL 242mm & CFF 244mm. The Products mentioned on the attached list are agreed to move to the Hoonga Blister Machine as per mentioned dimensions (list attached). A/FOIL 236mm & CFF 238mm, Dimension of unit carton and DI will also change as per the requirement of Hoonga blister machine tool. RA-0021-24Approved30/05/2025OpenedPharma1) Transfer of machine. 2) Area qualification will be conducted. 3)Installation of machine (IQ,OQ) will be performed Performance qualification 4) (PQ) will be performed 5) SOP of machine will be prepared 6) Training on machine will be provided 7) Priority list will be provided of transferring of products. 8) Development and approval of artwork each product (as per the lsit) 9) Revision of BPR 10) BOM will update on SAP 11) codes will be opened for pkg materials 12) new consignment on SAP will be created along with PM task list. 13) Consumption of existing inventory of packaging materials. 1) Machines has been transferred. 2) Done 3) IQ, OQ has been performed. 5) SOP has been prepared. 6) Done 7) Done 8) Artwork developed. 1) MAY-24 2) JULY-24 3) AUG-24 4) DEC-24 5) AUG-24 6) AUG-24 7) AUG-24 8) AUG-24 9) APR-25 10) APR-25 11) MAY-24 12) MAY-24 13) Mar-25 17/04/202402/08/2024Hafsa FatimaHamza Ahmed
CMP-0078-2419/04/2024Production/Non-CephPermanent Major Revision of Yield standard yield of the products is not achieving as per mentioned limits in BMR and BPR. (Product list attached as Annexure 1) To revise the yield limit of products in BMR & BPR (As mentioned product list Annexure 1) as per previous trend of the yield. N/AApproved 28/02/2025OpenedPharma1) Batch document (BPR) will be revised Feb-25 19/04/202425/04/2024Hafsa FatimaHafsa Fatima
CMP-0079-2424/04/2024Regulatory AffairsPermanentMinorIncoporation of correct registration number on the packaging of Xplended 10mg (Philippines). Previously mentioned registration number on the packaging of Xplended 10mg is DR -XY 44543.Updated registration number will be printed on the packaging ofXplended 10mg i.e. DRP-12702N/AApproved28/06/2024ClosedPharma1. Artwork will be revised 2. Regulatory approval required 3. New Item code will be opened 4. Existing code will get deleted 5. Existing inventory will proceed for destruction 6. Availability of new inventory as per the new item code artwork 7. Revision of BOM, BPR 8. Issuance of 1st batch No. of the product on which this change will be implemented 1) Done 2) Done 3) Done 4) Done 5) Done 6) Done 7) Done 8) Done 1) Apr-24 2) Apr-24 3) Apr-24 4) June-24 5) After completion of batch #4C122 6) June-24 7) June-24 8) June-24 24/04/202414/06/2024Hafsa FatimaHafsa Fatima
CMP-0080-2427/04/2024QAPermanent Major Manufacturing of commercial batches of ZI-AD Syrup 10mg/5mlZi-AD Syrup 10mg/5ml proposed WHO prequalified product whose commercial batch has not yet manufactured at site.It is proposed to manufacture a commercial scale batch of ZI-AD syrup (10mg/5ml) in the pharmEvo facility. RA-0023-24Approved 31/12/2024OpenedPharma1) Availability of Raw material and SAP codes. SCM 2) Availability of packaging material and SAP codes. SCM/QC(Pkg) 3) Approved artwork will be developed with specifications. QC(Pkg) 4) Analytical testing method for Finished product (FP) is required. QC 5) Re-fresher training to analyst is required. QC 6) Analytical Method Verification is required. QC 7) New Equipment’s IDs will be provided. Engineering 8) Batch documents (BDR, BMR, BYS, BPR) will be updated on new format. QA 9) Revision of SAP BOM for Packaging process. QA 10) Re-fresher training will be provided to all stakeholders on BMR. QA 11) Process validation will be performed. QA-VAL 12) Sample send to outsource lab for NDMA testing. QC 13) Cleaning validation will be performed. QA-VAL 14) Hold time study will be performed. QA-VAL 15) Product will charge on stability. QC 1)Done 2)Done 3)Artwork has been developed. 4)Done 5)Done 6)Done 7)Done 8)Batch document has been prepared. 9)Done 10)Refresher training has been provided to stakeholders. 1) Done 2) Done 3) May-24 4) Done 5) Apr-24 6) Done 7) Done 8) May-24 9) May-24 10) May-24 11) Oct-24 12) Nov-24 13) Nov-24 14) Oct-24 15) Nov-24 27/04/202430/05/2024Hafsa FatimaHafsa Fatima
CMP-0081-2427/04/2024QAPermanent Major Manufacturing of commercial batches of Zi-Ad Dispersible 20mg Tablet Zi-Ad Dispersible 20mg Tablet proposed WHO prequalified product whose commercial batch has not yet manufactured at site. It is proposed to manufacture a commercial scale batch of Zi-Ad Dispersible 20mg Tablet in the Pharmevo facility.RA-0024-24Approved 30/08/2024OpenedPharma1. Availability of Raw material and SAP codes SCM 2. Availability of packaging material and SAP codes SCM/ QC (Pkg) 3. Approved artwork will be developed with specifications. QC (Pkg) 4. Qualification of granulation & compression area according to required environmental conditions QA-Val/ Engineering 5. Analytical testing method for Finished product (FP) is required QC 6. Re-fresher training to analyst is required QC 7. Method Verification is required QC 8. New Equipment’s IDs will be provided Engineering 9. Batch documents (BDR, BMR, BYS, BPR) will be prepared on new format QA 10. Revision of SAP BOM for Packaging process QA 11. Re-fresher training will be provided to all stakeholders on BMR QA 12. Process validation will perform QA(Val) 13. Sample send to outsourcing lab for NDMA testing QC 14. Cleaning Validation will be performed QA(Val) 15. Hold time study will be performed QA(Val) 16. Product will charge on stability QC 1) Done 2) Done 3) Artwork has been developed. 4)Done 5) Done 6) Done 7) Done 8) Done 9) Batch documents have been prepared.10) Done 11) Refresher training has been provided to all stakeholders. 1) Done 2) Done 3) May-24 4) May-24 5) done 6)April-24 7) done 8) May-24 9) May-24 10) May-24 11) May-24 12) Oct-24 13) Nov-24 14) Nov-24 15) Dec-2024 16) Nov-24 27/04/202430/05/2024Hafsa FatimaHafsa Fatima
CMP-0082-2429/04/2024SCMPermanentMajorAdditional source induction of EmpagliflozinWe have approved source of Empagliflozin M/s. Fuxin Long Rui Pharmaceutical Co LtdWe intend to induct one more source M/s. Hangzhou Huadong Medicine Group Zhejiang Huayi Pharmaceutical Co., Ltd. Address: No. 15 Shuang Feng Rd., Fotang, Yiwu, Zhejiang Province:N/AApproved  OpenedPharma1. Technical documents will be submitted to QA SCM 2. Procurement of Material from New source SCM 3. Process validation will be performed QA-VAL 4. Product will charge on stability QC 5. vendor list will be updated after source approval 1. Done 1) May 24 2) May 25 3) Dec 25 4) Dec 25 5) Oct-24 29/04/202410/05/2024Hafsa FatimaHafsa Fatima
CMP-0083-2429/04/2024SCMPermanentMajorAdditional source induction of LinagliptinWe have one approved source for Linagliptin as M/s JIANGSU YONGANWe intend to induct one more source M/s. Lee Pharma Limited. SYNO.10/G-1, GADDAPOTHARAM(V), JINNARAM (M), SANGAREDDY (D) TELANGANA STATE 502319,TELANGANA STATE,INDIAN/AApproved 31/12/2025OpenedPharma1. Technical documents will be submitted to QA SCM 2. Procurement of Material from New source SCM 3. Process validation will be performed QA-VAL 4. Product will charge on stability QC 5. vendor list will be updated after source approval In Progress 1) Oct-24 2) May-25 3) Dec-25 4) Dec-25 5) Oct-24 29/04/202406/05/2024Hafsa FatimaHafsa Fatima
CMP-0084-2404/05/2024QAPermanent Major Induction Of Torque tester in QA IPC Lab Torque tester was not available in QA IPC Lab Induction of torque tester in QA Lab to check torque of filled syrup bottles.N/AApproved 01/05/2024ClosedPharma1.Installation of Torque tester 2.Calibration of torque tester 3.Callibration list will be updated 4.performnce qualification will be performed 5.SOP will be performed 6.Training on SOP will be provided 7.IPC SOP will be revised 8.Training on IPC SOP will be provided. All action plans executed May-24 May-24 May-24 May-24 May-24 May-24 May-24 May-24 04/05/202416/05/2024Hafsa FatimaHafsa Fatima
CMP-0085-2406/05/2024Engineering Permanent Minoronline monitoring and data logging system Oof purified water Currently in purified water plant we are manually monitoring and maintaining logbooks from online conductivity meter and temperature and conductivity of both loops serving in non-ceph and ceph area.It is proposed to install an online temperature and conductivity monitoring and data logging system of purified water running in loop of non-ceph and ceph area.N/AApproved 31/05/2024ClosedPharma1) Qualifiactio will be performed 2) SOP will be revised 3) Training on SOP will be provided Qualification has been performed. 2) SOP has been revised. 3) Training has been provided. 1) Aug-24 2) Aug-24 3) Aug-24 06/05/202420/08/2024Hafsa FatimaHamza Ahmed
CMP-0086-2406/05/2024Production Permanent MinorAddition of Thermal Transfer OverprintCurrently, rubber stamps have been used for printing of Batch No. & Epiry Date on A/Foil of Sachet during filling operation.It is proposed to install new Thermal Trasnfer Overprint for printing of Batch No. & Expiry Date on A/Foil of Sachet during filling operation.N/AApproved 31/10/2024OpenedPharma1) Qualification will be performed 2) SOP will be updated and Training on SOP will be provided 3)BPR of sachet will be revised 1) Qualification has been performed. 2) Done 1) Aug-24 2) Aug-24 3) Oct-24 06/05/202431/07/2024Hafsa FatimaHafsa Fatima
CMP-0087-2416/05/2024SCMTemporaryMinorBestrix lgm IV injection | Reduce in batch size Currently the batch size ofBestrix lgm IV injection is 20kg.Batch size ofbestrix lg injection need to be reduced to 10kg from 20kg due to difference in potency of remaining lots.N/AApproved 31/05/2024ClosedPharmaBatch document will be issued manually batch document issued 30/06/2024 16/05/202412/06/2024Hafsa FatimaHafsa Fatima
CMP-0088-2421/05/2024SCMPermanent Major Change of Coating Materials in Specified Finished ProductsOpadry Coating Materials are currently being utilized in Specified Finished Products mentioned in Attached Sheet.We Propose to change Opadry Coating materials with Specific Coating materials while Quantity will remain same in BOM.N/AApproved 31/10/2024OpenedPharma1) For XR range PD trials will be performed 2) trial stability will be conducted 3) BOM and BPR will be revised 1) June-24 2) June-24 3) oct-24 21/05/202424/06/2024Hafsa FatimaHafsa Fatima
CMP-0089-2423/05/2024SCMPermanent Major Additional source induction of Dapagliflozin Propanediol Mono hydrateWe have existing source of Dapagliflozin Propanediol Monohydrate M/s. Jiangsu Yongan PharmaceuticalWe intend to induct one more source Mis. Weifang Hishine Pharmaceutical Co., Ltd. Address: Li'ao Road, Binhai Chemical Zone of Changyi, Weifang City, Shandong Province, China.N/AApproved 30/08/2024OpenedPharma1. Technical documents will be submitted to QA SCM 2. Procurement of Material from New source SCM 3. Process validation will be performed QA-VAL 4. Product will charge on stability QC 5. Vendor list will be updated. 1) Done 5) Done 1) july-24 2) Aug-24 3)Dec-24 4) Dec-24 5)Aug-24 23/05/202418/09/2024Hafsa FatimaHamza Ahmed
CMP-0090-2423/05/2024QC (PKG)TemporaryMinorUnit carton of Telsarta 40mg and Evopride Plus 1/500mg received on low grammage Currently, Unit carton ofTelsarta 40mg 10's batch # 0000043316 and Unit carton Evopride Plus 1/500mg 30's batch# 0000043317 is received on Grammage 210g/m2 for local marketIt is proposed to utilize Unit carton of Telsarta 40mg JO's batch# 0000043316 and Unit carton Evopride Plus 1/500mg 30's batch # 0000043317 received quantity only i.e. 6,580 EA and 32,970 EAN/AApproved 31/07/2024ClosedPharma1) GRN will be released 2) Telsarta U/C will be consumed in batch 4D168 3) Evopride U/C will be consumed in next two batches 1) GRN has been released. 2) Done 3) Done 1) May-2024 2)July-2024 3) July-2024 23/05/202414/06/2024Hafsa FatimaHafsa Fatima
CMP-0091-2410/06/2024WarehouseTemporaryMinorUse of Nutraceutical dispensing booth printer in non-ceph dispensing boothCurrently in dispensing booth 01 of non-ceph, Printer ID WB-NCP-Wh-04 is in use but due to an unknown reason it is out of order and we have batches to dispensed.The printer ID WB-NUT-WH-01 of nutraceutical dispensing booth is idle which we can use in non-ceph for smooth ongoing of dispensing process.N/AApproved28/06/2024ClosedPharma1) Rectification of non-ceph's printer WH 2) Nutra printer will shift to original location - WH 1) Done 2) Done 1) June-2024 2) June-2024 10/06/202430/07/2024Hamza Ahmed Hamza Ahmed
CMP-0092-2411/06/2024SCMPermanentminorchange in manufacturer nameWe have approved MANUFACTURER by the name of M/s APARNA ORGANICS LIMITED, Survey No:78,79,80& 145 ,Chittivalasa (V),Pydibimavaram (panchayat) , Ranastalam (M) Srikakulam (Dist) , Andhra Pradesh , IndiaThis is to inform you that the name of company has been changed from M/s APARNA ORGANICS LIMITED to M/s APARNA PHARMACEUTICS PRIVATE L;IMITED and adsress will remain as per our existing approved source. New SAP CODE WILL BE OPENED AND PREVIOUS CODE WILL BE BLOCKED. N/AApproved31/08/2024ClosedPharma1) Vendor List will be updated.QA 2) New manufacturer name will be updated in LIMS.QC 1) Done 2) Done 1) Sep-24 2) Sep-24 11/06/202406/09/2024Hafsa FatimaHamza Ahmed
CMP-0093-2411/06/2024International businessPermanentmajorArtwork change of Evorox Inj 750mg - kenyaIn kenya, existing artwork is very old and not attractive.(existing artwork is attached)Need to change the design to make our pack more attractive, using the same artwork i.e. already in use for Afghanistan. But, will not print MRP on the packN/AApproved31/10/2024ClosedPharma1) Regulatory approval is required 2) BOM will be prepared. 1) Done 2) Done 1) Oct-2024 2) July-2024 11/06/202415/08/2024Hafsa FatimaHamza Ahmed
CMP-0094-2411/06/2024business developmentPermanentmajorLaunch of Klevra(levetiracetam) 500mg tablets in pack size of 30's in PhiliphinesThis product is only available in pack size of 90' in Philiphinesthe product Klevra (levetiracetam) 500md tablets will be launched in additional pack size of 30's in philiphinesN/AApproved31/10/2024OpenedPharma1. Product launch in Philippines BD 2. Development and approval of artwork BD 3. Item code will open for new developed artwork QC PKG 4. FG codes will be opened SCM 5. Specification will be updated QC PKG 6. BOM will create on SAP QA 7. BPR will be prepared QA 1) In progress will be launched in sep-24. 2) Done 3) Done 4) Done 5) Done 6) Done 7) Done 1) Aug 2024 2) jun-2024 3) jun-2024 4) july-2024 5) Aug-2024 6) Aug-2024 7) Aug-2024 11/06/202402/08/2024Hafsa FatimaHamza Ahmed
CMP-0095-2413/06/2024SCMPermanent MinorChange in Manufacturer nameWe have approved MANUFACTURER for Omeprazole Pellets 12.5% by the name of/s RA CHEM PHARMA, Plot No. A-19/C,A-23A & A-23B, Road.No. I 8, I.D.A., Nacharam,Medchal-Malkaj giri District_ -500076. Telangana, India.This is to inform you that RA CHEM PHARMA has merged with Cohance Lifesciens Limited and manufacturing site address will be remain same as per our existing approved source. New Supplier SAP CODE WILL OPENED AND PREVIOUS CODE WILL BE BLOCKED.N/AApproved 30/09/2024ClosedPharma1) Vendor List will be updated.QA 2) New manufacturer name will be updated in LIMS.QC 1) Done 2) Done 1) Sep-24 2) Sep-24 13/06/202406/09/2024Hafsa FatimaHamza Ahmed
CMP-0096-2414/06/2024Business Development PermanentmajorLaunch of products for Tender in Somalia.The below mentioned products are not launched in Somalia yet: 1. K-1000 Tablets 2. Shevit Tablets ,., 3. Neo-Q 10 Tablets 4. Supercran Sachet 5. Orslim Capsules 6. Finno-Q Sachet 7. Opt-D Capsules 200,000IUThese products are planned for launch in Somalia for Tender business. N/AApproved31/12/2024ClosedPharma1) Local packs will be supplied 1) Products has been supplied. 1) Dec-2024 14/06/202406/09/2024Hafsa FatimaHamza Ahmed
CMP-0097-2414/06/2024Business Development PermanentmajorLaunch of products in Local market through Contract ManufacturingThe below mentioned products are not launched in the local market yet: 1. Mometasone 50mcg- Nasal Spray (1 's). 2. Naproxen + Esomeprazole 500mg/20mg - Tablets (28's). 3. Ipratropium Bromide 0.025% - Inhalation Solution (5's). 4. Ipratropium Bromide+ Salbutamol 0.5mg/2.5mg - Inhalation Solution (5's). 5. Paracetamol+ Tramadol HCL 325mg/37.5mgTablets (20's).These products are planned for launch in the Local market through Contract ManufacturingN/AApproved31/01/2025OpenedPharma1)Availability of registration letter with brand name 2) Artwork will be developed after confirmation of brand name 3) artwork will be reviewed and approved and forward to manufacturer 4) contract manufacturing lost will be updated 5)New code for finished product will be opened after brand name approval 6) 1st 3 batches will be tested in pharmEvo 1) Sep-2024 2) Oct-2024 3) Oct-2024 4) Oct-2024 5)Oct-2024 6) Jan-2025 14/06/202420/06/2024Hafsa FatimaHafsa Fatima
CMP-0098-2424/06/2024Product DevelopmentPermanentMajorChange ofbatch size of Actiflor sachet from 21621 sachets to 20000 sachets and a set of two batches will be manufactured together always. Change in environmental conditions of manufacturing and filling process of saccharomyces boulardii i.e. temperaActiflor sachet is being manufactured with batch size of 16kg (21621 sachets) in two lots of 8kg each. • Manufacturing and filling of Actiflor sachet is done at temperature NMT 30°C and RH NMT 65%Following changes are proposed: • saccharomyces boulardii will be procured in pack size of 10kg intact bag by the supplier. • To avoid oxidation ofAPI, two batches of actiflor sachet will be manufactured together to comsume 10kg API bag. Actiflor sachet batch size will be changed to 20,000 sachets. • Manufacturing and filling ofActiflor sachet will be done at temperature NMT 20°C ±2C and RH: 35% ±5%.RA-0027-24Approved31/03/2025OpenedPharma1) SCM will ensures the procurement of intact 10Kg API. 2) Area Qualification will be performed. 3) BOM and Batch Document will be revised accordingly. 4) Process Validation will be performed 5) Process validation batches will be charged on stability. 1) From next supply 2) Nov-24 3) Dec-24 4) Feb-25 5) Feb-25 24/06/202415/11/2024Zafran MeerHamza Ahmed
CMP-0099-2424/06/2024Business Development PermanentMajorDevelopment of new punch/standard tool for Physician sample of Sri LankaPhysician Samples in Sri Lanka are being supplied either by cutting or folding the commercial blisters.New Punch/ standard tool for Physician Samples Sri Lanka will be developed.N/Aun approved ClosedPharma 24/06/202427/06/2024Zafran MeerHafsa Fatima
CMP-0100-2424/06/2024QCPermanentMajorInstallation of walking chamber in QCCurrently, standalone stability chamber is used to perform stability study of Pharmevo products. It is proposed to install one walk-in stability chamber in QC.RA-0029-24Approved31/10/2024ClosedPharma1) Thermal mapping will be performed. 2) Sop for walking chamber will be prepared. 3) Training will be provided to concern staff. All actions has been completed. 1) Sep-24 2) Sep-24 3) Sep-24 24/06/202410/09/2024Zafran MeerHamza Ahmed
CMP-0101-2425/06/2024SCMTemporaryMinorIssuance of picklist without SAP system determinationCurrently picklist is being issue through SAP system.It is proposed to issue the picklist of Evofix suspension 60ml(PHL) B.No 4G227,4G228, 4G229, 4G230, 4G231 without SAP system determination.N/AApproved01/06/2024ClosedPharma1) Manual picklist will be issued. 2) Rectification of SAP error. 3) Picklist will be issued against mentioned batches via SAP for inventory management. 1) Done 2) Done 3) Done 1) Jun-2024 2) Jun-2024 3) Jun-2024 25/06/202412/08/2024Zafran MeerHamza Ahmed
CMP-0102-2427/06/2024BDPermanentMajorNew products Launch in KosovoThe below-mentioned products are not launched in Kosovo yet. 1. Erli (Empagliflozin) Tablets 10mg (14’s) 2. Erli (Empagliflozin) Tablets 25mg (14’s)It is proposed to launch these products in Kosovo.N/AApproved30/09/2024ClosedPharma1. Registration Letter required RA 2. Product launch in Kosovo BD 3. Development and approval of artwork QC PKG 4. Item code will open for new developed artwork QC PKG 5. FG codes will be opened SCM 6. Specification will be updated QC PKG 7. BOM will create on SAP QA 8. BPR will be prepared QA 1) Done 2) Done 3) Done 4) Done 5) Done 6) Done 7) Done 8) Done 1) July-24 2) Aug-24 3) July-24 4) July-24 5) July-24 6) Aug-24 7) Oct-24 8) Oct-24 27/06/202429/08/2024Zafran MeerHamza Ahmed
CMP-0103-2427/06/2024BDPermanentMajorLaunch of products in Local market through Contract ManufacturingThe below mentioned products are not launched in the local market yet. 1. Budesonide (Generic Name) Nebulization suspension 2. Dutasteride+Tamsulosin HCL (Generic name) Capsule 3. K-1000 Plus SachetThese Product are planned for local in the local market through contract manufacturing.N/AApproved OpenedPharma1) Availability of registration letter with brand name. 2) Artwork will be developed after confirmation of brand name. 3) Artwork will be reviewed, approved and forwarded to manufacturer. 4) Contract manufacturing list will be updated 5) New code for finished product will be opened after brand name approval. 6. 1st three batches will be tested in Pharmevo. 1) Sep-2024 2) july-2024 3) Aug-2024/Sep-2024 4) Oct-2024 5) Sep-2024 6) Dec-24 27/06/202411/07/2024Zafran MeerHafsa Fatima
CMP-0104-2401/07/2024Marketing Permanent MinorAddition of DGP Army order.Institution order for Ramipace 2.5mg and Dapwiz 10mg is received from DGP Army, and no separate BOM and artwork is available for these product for Army DGP order.New artwork is required for A/F and U/C to fulfill the requirement of order therefore, separate codes will be open for A/F , UC and BOM of Ramipace 2.5mg, Stamping Pakistan Defence Forces with army arrowmark and Cat Part No. NIF/6505-74-310-2953 will be used with black ink and for Ramipace 2.5mg and Cat Part No. NIF/6505-74-310-0945 will be used with blank ink for Dapwiz 10mg on both A/f and U/C. Dapwiz 10mg. M/C (MC-20) 5ply (1200000684) will be used. Base printing color of aluminum foils will be green. Dapwiz Tab. 10mg CP lXlO'S - 40,000 Packs Ramipace Tab. 2.5mg CP 2X14'S - 40,178 Packs BOM Description: Ramipace Tab. 2.5mg CP DGDP Inst 14'S Dapwiz Tab. 10mg CP DGDP Inst l0'SN/AApproved31/10/2024OpenedPharma1) Development and approval of artwork. 2) Item codes (packaging) will be opened. 3) FG codes will be opened. 4) BOM and BPR will be prepared. 5) Specifications will be update on LIMS. 1. Done 2. Done 3. Done 4. BOM has been prepared BPR under process and within timelines 5. Done 1) July-24 2) July-24 3) July-24 4) Oct-24 5) July-24 01/07/202423/08/2024Hafsa FatimaHamza Ahmed
CMP-0105-2403/07/2024Production/Non-CephPermanent MinorChange in thickness limit Spectrix 500mg TabletCurrently, the thickness limit of spectrix 500mg tablet is 5.70mm (5.40~6.00)mm.It is proposed to revise the thickness limit of spectrix 500mg Tablet from 5.70 (5.40~6.00)mm. to 5.30mm(5.00~5.60)mmN/AApproved31/01/2025OpenedPharma1) Batch documents will be revised. 2) Process validation will be performed. 3) Finished product specification will be revised. 4) LIMS will be updated with new thickness limit. 5) Relevant part of the dossier will be updated. 1) Dec-24 2) Dec-24 3 Sep-24 4) Sep-24 5) Jan-25 03/07/202411/07/2024Hafsa FatimaHafsa Fatima
CMP-0106-2404/07/2024Business Development Permanent Major New products launch in Kenya.The below-mentioned products are not launched in Kenya yet. 1. Evopride (Glimepiride) Tablets 1mg (20's) 2. Estar (Escitalopram) Tablets 10mg (I O's) 3. Zi-AD (Zinc Sulphate) Syrup 10mg/5ml (60ml) 4. Zi-AD (Zinc Sulphate) Tablets 20mg (I O's) 5. Ferfer (Iron+ Vitamin C+ Vitamin B12) Sachet (30's) 6. Kalsob (Calcium+Vitamin D3 + Vitamin K;) Tablets (30's)It is proposed to launch these products in Kenya.N/AApproved31/01/2025OpenedPharma1. Product launch in Kenya BD 2. Development and approval of artwork BD 3. Item code will open for new developed artwork QC PKG 4. FG codes will be opened SCM 5. Specification will be updated QC PKG 6. BOM will create on SAP QA 7. BPR will be prepared QA. 8. Shelf life for export product lsit will be updated. 3) Done 4) Done 1) Dec-24 2) Oct-24 3) Aug-24 4) Aug-24 5) Dec-24 6) Dec-24 7) Dec-24 8) Feb-25 04/07/202422/08/2024Hafsa FatimaHamza Ahmed
CMP-0107-2409/07/2024SCMPermanent Major Additional source induction of Hydroxy Propyl CelluloseWe are currently procuring Excipient: Klucel LF- Hydroxy Propyl Cellulose from M/s AshlandWe intend to induct one more source M/s. TAIAN RUITAI CELLULOSE CO., LTD CHINA. ADDRESS: WENYANG TOWN, FEICHENG CITY, SHANDONG PROVINCE, CHINAN/AApproved 31/10/2024ClosedPharma1.Source approval documents are required as per the check list of required documents. SCM 2. approved Vendor list will be updated. QA 1) Done 2) Done 1) Aug-2024 2) Oct-2024 09/07/202406/09/2024Hafsa FatimaHamza Ahmed
CMP-0108-2424/07/2024PDPermanent MinorAddition of new weighing balance in PD areaCurrently PD have following quantity of weighing balance in granulation area. AND GF 300(Balance) Min=0.02g Max=310g Quantity = 02PD have received weighing balance from warehouse with operational condition also following instrument will be added in PD granulation area. AND GF 600(Balance) Min=0.02g Max=610g Quantity = 01N/AApproved31/10/2024OpenedPharma1) Calibration and calibration of balance will be performed. 2) SOP will be prepared. 1) Oct-24 2) Sep-24 24/07/202418/11/2024Hamza Ahmed Hamza Ahmed
CMP-0109-2425/07/2024BDPermanent MinorPrinting of price in AFN currency on packs of AfghanistanCurrently, we are supplying the below mentioned products to Afghanistan, with the price printed in PKR. 1. Gouric 40mg Tablet 2. Gouric 80mg Tablet 3. Xilica 50mg Cap 4. Xilica 75mg CapThese products will be supplied to Afghanistan with price printed in AFN with 2D ,matrix.N/AApproved30/09/2024ClosedPharma1) Price list will be updated after receiving the price from finance. QA 2) GTIN will be issued by QC. Closed without implementation 1) Sep-24 2) Sep-24 25/07/202420/08/2024Hamza Ahmed Hamza Ahmed
CMP-0110-2430/07/2024QCPermanentmajorShifting from data reporting software LIMS to SAP for Ceph and Non-Ceph QC LaboratoryCurrently, all test reporting in QC has been done by LIMS software for Ceph and non-ceph QC laboratory.It is proposed to shift the data reporting system from LIMS to SAP for Ceph and non-Ceph QC Laboratory.N/AApproved OpenedPharma1) Testing specification of Raw material,finshed good,packaging and stability will be developed in SAP. QC 2) SOP will be prepared. QC 3) Training will be performed. QC 4) Software validation will be performed. IT 1) Nov-24 2) Nov-24 3) Nov-24 4) Nov-24 30/07/202421/08/2024Hamza Ahmed Hamza Ahmed
CMP-0111-2403/08/2024BDPermanent MajorNew products launch in Sri LankaThe below mentioned products are not launched in Sri Lanks yet. 1. Avsar tab 80/5 mg 2. Avsar tab 160/5 mg 3. Zilero tab 2.5 mg 4. Zilero tab 5 mg 5. Bongard tab 70mg (re-launch)It is proposed to launch these products in Sri Lanka.N/AApproved31/01/2025OpenedPharma1) Registration Letter required RA 2) Product launch in Sri Lanka BD 3) Development and approval of artwork BD 4) Item code will open for new developed artwork QC 5) FG codes will be opened SCM 6) Specification will be updated QC 7) BOM will create on SAP QA 8) BPR will be prepared QA 9) Shelf life for export product list will be updated. QA 1) Registration letter of Avsar 80/5mg tab , Avsar 160/5mg tab and bongard tab submitted. 5) FG codes opened 1) Sep-24 2) Oct-24 3) Aug-24 4) Aug-24 5) Sep-24 6) Dec-24 7) Oct-24 8) Oct-24 9) Jan-25 03/08/202430/08/2024Hamza Ahmed Hamza Ahmed
CMP-0112-2403/08/2024BDPermanent MajorNew products launch in TajikistanThe products mentioned in the attached list are not launched in Tajikistan.It is proposed to launch these products in Tajikistan. N/AApproved31/01/2025OpenedPharma1) Registration Letter required RA 2) Product launch in Tajikistan. BD 3) Development and approval of artwork BD 4) Item code will open for new developed artwork QC 5) FG codes will be opened SCM 6) Specification will be updated QC 7) BOM will create on SAP QA 8) BPR will be prepared QA 9) Shelf life for export product list will be updated. QA 4) Item code has been opened. 4) FG codes has been opened. 6) BOM has been created. 1) Dec-24 2) Oct-24 3) Aug-24 4)Aug-24 5) Sep-24 6) Mar-25 7) Oct-24 8) Oct-24 9) Jan-25 03/08/202430/08/2024Hamza Ahmed Hamza Ahmed
CMP-0113-2403/08/2024BDPermanent MajorNew products launch in GhanaThe below mentioned products are not launched in Ghana yet. 1. Rastor tab 5mg 2. Avsar tab 80/5 mg 3. Evogab Cap 150mgIt is proposed to launch these products in Ghana. N/AApproved31/01/2025OpenedPharma1) Registration Letter required RA 2) Product launch in Ghana. BD 3) Development and approval of artwork BD 4) Item code will open for new developed artwork QC 5) FG codes will be opened SCM 6) Specification will be updated QC 7) BOM will create on SAP QA 8) BPR will be prepared QA 9) Shelf life for export product list will be updated. QA 1) Done 3) Done 4) Done 5) Done 6) 1) Already done 2) Oct-24 3) Already done 4) Already done 5) sep-24 6) Already done 7) Oct-24 8) Oct-24 9) Jan-25 03/08/202430/08/2024Hamza Ahmed Hamza Ahmed
CMP-0114-2407/08/2024QCPermanent MajorIntroduction of pharma code on packaging materialCurrently Pharmacode is not printed on the packaging material.It is proposed to be revised packaging material for implementation of pharmacode related to the products running on hoonga machine.N/AApproved30/06/2025OpenedPharma1) Artwork will be developed. 2) New item code will be opened 3) Specification will be updated in LIMS. 4) BOM will be revised. 1)Nov-24 2) Apr-25 3) Sep-25 4) Apr-25 07/08/202408/08/2024 Hamza Ahmed
CMP-0115-2413/08/2024QAPermanent  Induction of New Apparatus (Galvano Scientific) in QA IPC lab (Non-Ceph)Currently we have one DT apparatus is available in QA IPC lab.It is proposed to induct one more DT apparatus in QA IPC lab.N/AApproved30/09/2024ClosedPharma1) IQ,OQ and PQ will be performed. 2) Calibration list will be updated. 3) SOP will be prepared. 4) Training will be provided to concern staff. 1) Done 2) Done 3) Done 4) Done 1) Sep-24 2) Sep-24 3) Sep-24 4) Sep-24 13/08/202410/09/2024Hamza Ahmed Hamza Ahmed
CMP-0116-2421/08/2024RAPermanent MinorChange in Name of Business PartnerCurrently following products are manufactured by Pharmevo (Pvt) LTD. and marketed by Criticare Pharmaceuticals: 1) Aprep 80mg Tablet 2) Aprep 125mg Tablet 3) SPS 15g Jar 4) SPS 100g Jar Now the Criticare Pharmaceuticals has revised its name and new name of Company is Criticare Pharmaceuticals (Pvt) LTD. 1) Aprep 80mg Tablet 2) Aprep 125mg Tablet 3) SPS 15g Jar 4) SPS 100g JarN/AApproved31/12/2024OpenedPharma1) Consumption of old inventory. 2) Artwork will be developed. 3) New codes will be opened. 4) BOM will update on SAP. 1) Jan-25 2) Oct-24 3) Oct-24 4) Dec-24 21/08/202422/08/2024Hamza Ahmed Hamza Ahmed
CMP-0117-2421/08/2024SCMPermanent MinorInstitution orders of MSD with new packaging Currently, no any separate artwork is available for the institution order (MSDs Sindh Govt). Products are mentioned in the attached list.Separate artwork of Aluminum foil will be developed for the institution order(MSDs Sindh Govt). A/F will be printed with red ink color as “Sindh Govt. Property Not for Sale with Sindh Govt. Logo with the Green base Color of blister.” Institution green box will be used instead of Unit carton.N/AApproved31/12/2024In ProgressPharma1) Development and approval of artwork. BD 2) Item code will open for new developed artwork QC 3) FG codes will be opened. SCM 4) Specification will be prepared for new developed artwork. 5) BOM will be created on SAP. 6) BPR will be prepared. 3) FG code has been opened. 1) Sep-24 2) Sep-24 3) Sep-24 4) Dec-24 5) Nov-24 6) Nov-24 21/08/202413/11/2024Hamza Ahmed Hamza Ahmed
CMP-0118-2430/08/2024SCMTemporaryMinorConversion of Afghanistan order into local CPSpectrix 250ng Tab (B#No 4H168, Qty: 15,152) and Zoltar 40mg Cap (B#4H230, Qty: 18000) were planned in Afghanistan order. Blistering has been completed or these orders. Artwork for Afghanistan and CP is same, only MRP will be PKR. After completion of the packaging process, batch will be released in Afghanistan code, then quantity will be transferred into local CP code in SAP.N/AApproved31/01/2025OpenedPharma1) On unit carton qty will be printed in PKR. 2. Packaging will be performed as per BPR. 3. Batch will be released in same Afghanistan code. 4. Manual Batch released with BPR of CP. 5. At the time of release MRP will not be mentioned. Intimation of MRP will be provided to email to finance and other stakeholders. 6) FG code will be transfer from afg code to local CP code. 1) Sep-24 2) Sep-24 3) Sep-24 4) Sep-24 5) Sep-24 6) Sep-24 30/08/202410/09/2024Hamza Ahmed Hamza Ahmed
CMP-0119-2405/09/2024QCPermanent  Shifting from the manual inventory management of stability samples to SAP inventory module.Currently inventory of stability samples are allocated in the excel sheet of sample inventory of stability samples as per the SOP of Stability Studies QCG/5/016.Now, it is propose to transfer the manual inventory management system to SAP inventory management. under Approval OpenedPharma 05/09/2024 Hamza Ahmed  
CMP-0120-2406/09/2024SCMPermanent MajorAdditional source of CrosspovidoneWe are currently procuring Excipient: Crosspovidone from M/s. AshlandWe intend to induct one more source M/s. Boai NKY Medical Holdings Ltd., Address: No.1888 East Wenhua Road, Boai, Jiaozuo, Henan, China N/AApproved30/09/2024ClosedPharma1.Source approval documents are required as per the check list of required documents. SCM 2. approved Vendor list will be updated. QA 1) Done 2) Done 1) Sep-24 2) Sep-24 06/09/202428/09/2024Hamza Ahmed Hamza Ahmed
CMP-0121-2406/09/2024SCMPermanent MajorAdditional source of Co-PovidoneWe are currently procuring Excipient: Copovidone K-28 from M/s. AshlandWe intend to induct one more source M/s. Boai NKY Medical Holdings Ltd., Address: No.1888 East Wenhua Road, Boai, Jiaozuo, Henan, China N/AApproved30/09/2024ClosedPharma1.Source approval documents are required as per the check list of required documents. SCM 2. approved Vendor list will be updated. QA 1) Done 2) Done 1) Sep-24 2) Sep-24 06/09/202428/09/2024Hamza Ahmed Hamza Ahmed
CMP-0122-2407/09/2024BDPermanent MajorNew product launch in Botswana.The below mentioned products are not launched in Botswana yet. 1. Utfix 0.4 mg Caps 2. Setspin 24mg TabletsIt is proposed to launched these products in Botswana.N/AApproved30/11/2024OpenedPharma1. Special import permit required. BD 2. Product launch in Botswana. BD 3. Development and approval of artwork. BD 4. Item code will open for new developed artwork. BD 5. FG codes will be opened. SCM 6. Specification will be updated. QC PKG 7. BOM will create on SAP. QA 8. BPR will be prepared. QA 1) Done 3) Done 4) Done 5) Done 7) Done Timelines are same for both products. 1) Permit Received 2) Nov-24 3) Done 4) Oct-24 5) Oct-24 6) Oct-24 7) Done 8) Oct-24 07/09/202426/10/2024Hamza Ahmed Hamza Ahmed
CMP-0123-2407/09/2024SCMPermanent MinorInstitution orders from Institution marketingCurrently, no any separate artwork is available fot the institution orders mentioned in the attached list.Separate artwork of Aluminum foil will be developed for the institution orders. Institution order requirement will be printed on the aluminum foil and institution green box will be used for the instead of unit cartons. N/AApproved30/11/2024OpenedPharma1. Development and approval of artwork. BD 2. Item code will open for new developed artwork. BD 3. FG codes will be opened. SCM 4. BOM and BPR will be prepared. QA 5. Specification will be updated. QC PKG Timelines is same for all products. 1) Oct-24 2) Oct-24 3) Nov-24 4) Nov-24 5) Nov-24 07/09/202426/10/2024Hamza Ahmed Hamza Ahmed
CMP-0124-2412/09/2024BDPermanent MajorNew products launch in Sri LankaThe below mentioned products are not launched in Sri Lanks yet. 1. Avsar tab 80/5 mg 2. Avsar tab 160/5 mg 3. Zilero tab 2.5 mg 4. Zilero tab 5 mg 5. Bongard tab 70mg (re-launch)It is proposed to launch these products in Sri Lanka.N/AApproved31/12/2024In ProgressPharma1) Product launch in Sri Lanka. BD 2) Development and approval of artwork BD 3) Item code will open for new developed artwork QC 4) FG codes will be opened SCM 5) Specification will be updated QC 6) BOM will create on SAP QA 7) BPR will be prepared QA Timelines are same for both products. 1) Dec-24 2) Already done 3) Already Done 4) Nov-24 5) Dec-24 6) Dec-24 7) Dec-24 12/09/202426/10/2024Hamza Ahmed Hamza Ahmed
CMP-0125-2416/09/2024BDPermanent MajorNew products launch in HondurasThe product mentioned in the attached list are not launched in Honduras yet.It is proposed to be launched these products in Honduras.N/AApproved31/01/2025In ProgressPharma1) Registration Letter required RA 2) Product launch in Honduras. BD 3) Development and approval of artwork BD 4) Item code will open for new developed artwork QC 5) FG codes will be opened SCM 6) Specification will be updated QC 7) BOM will create on SAP QA 8) BPR will be prepared QA 9) Shelf life for export product list will be updated. QA 1) Done 1) Registration Letter received. 2) Jan-25 3) Oct-24 4) Oct-24 5) Oct-24 6) Jan-25 7) Dec-24 8) Dec-24 9) Jan-25 16/09/202426/10/2024Hamza Ahmed Hamza Ahmed
CMP-0126-2416/09/2024Medical Affairs Permanent MinorChange in PIL of Anplag1) Ethnicity in pharmacokinetics in special populations is missing. 2) Incomplete information in overdosage. 3) The meaning of the letter "m" in the classification of "ADR of nervous system disorder (Uncommon: Intracranial haemorrhage) " is not provided. 1.PHARMACOKINETICS IN SPECIAL POPULATIONS Ethnicity: Patients of Asian descent have a 39% higher mean bioavailability compared to Caucasian patients. Patients self-identified as black had an 18% lower bioavailability of ticagrelor compared to Caucasian patients, in clinical pharmacology studies, the exposure (Cmax and AUC) to ticagrelor in Japanese subjects was approximately 40% (20% after adjusting for body weight) higher compared to that in Caucasians. The exposure in patients self-identified as Hispanic or Latino was similar to that in Caucasians. 2.NERVOUS SYSTEM DISORDERS Uncommon: Intracranial haemorrhage (m) m i.e. spontaneous, procedure related or traumatic intracranial haemorrhage 3.OVER DOSAGE The expected effect of excessive ticagrelor dosing is prolonged duration of bleeding risk associated with platelet inhibition. N/AApproved In ProgressPharma01) Intimation/Approval will be submitted. RA 02) Development and approval of artwork. BD 03) Item code will be opened. BD 04) Consumption of old inventory SCM 05) First consignment of new DI availability as per new item code. SCM 06) BOM will be revised as per new item code. (QA) 07) Specification will be Revised. QC Timelines for each component is different and mentioned in the attached excel sheet. 16/09/202418/11/2024Hamza Ahmed Hamza Ahmed
CMP-0127-2416/09/2024Medical Affairs Permanent MinorChange in PIL of KlevraErrors in the ramge of renal impairment, misplacement of table 1 classification Addition required in dosage and administration, administration requirements, warnings and precautions, & adverse reactions.I. Renal Impairment: (CLcr = 50--80 mL/min) EDITING REQUIRED. 2.DOSAGE AND ADMINISTRATION: Monotherapy for adults and adolescents over l6 years of age in partial onset seizures: Initiate treatment with a daily dose of 1000 mg/day, given as twice-daily dosing (500 mg twice daily). Additional dosing increments may be given (1000 mg/day additional every 2 weeks) to a maximum recommended daily dose of 3000 mg. There is no evidence that doses greater than 3000 mg/day confer additional benefit. 1 Adjunctive therapy for adults(>18 years) and adolescents (12 to 17 years) weighing less than 50 kg in partial onset seizures. myoclonic seizures and partial generalized tonic clonic seizures: The lowest effective dose should be used for all indications. The starting dose for a child or adolescent of 25kg should be 250mg twice daily with a maximum dose of 750mg twice daily. 3.Table of Renal Impairment (1) A 750 mg loading dose is recommended on the first day of treatment with levetiracetam. (2) Following dialysis, a 250 to N/AApproved In ProgressPharma01) Intimation/Approval will be submitted. RA 02) Development and approval of artwork. BD 03) Item code will be opened. BD 04) Consumption of old inventory SCM 05) First consignment of new DI availability as per new item code. SCM 06) BOM will be revised as per new item code. (QA) 07) Specification will be Revised. QC Timelines for each component is different and mentioned in the attached excel sheet. 16/09/202418/11/2024Hamza Ahmed Hamza Ahmed
CMP-0128-2416/09/2024Medical Affairs Permanent MinorChange in PIL of DapwizDetails in indication, dosage and administration, warning and precautions, & drug interaction is incomplete.Proposed change: 1.INDICATIONS: Chronic kidney disease: It is indicated in adults for the treatment of chronic kidney disease. 2.DOSAGE AND ADMINISTRATION: Chronic kidney disease: The recommended dose is 10 mg dapagliflozin once daily. 3.WARNING AND PRECAUTIONS Lactose: The tablets contain lactose. Patients with rare hereditary problems of galactose intolerance, 1 lactase deficiency or glucose-galactose malabsorption should not take this medicinal product. Cardiac failure: Experience with dapagliflozin in NYHA class IV is limited. Dapagliflozin should not be used in patients with type 1 diabetes mellitus. 4.DRUG INTERACTIONS Diuretics: Dapagliflozin may add to the diuretic effect of thiazide and loop diuretics and may increase the risk of dehydration and hypotension Effect of dapagliflozin on other medicinal products: Dapagliflozin may increase renal lithium excretion and the blood lithium levels may be decreased. Serum concentration of lithium should be monitored more frequently after dapagliflozin initiation and dose changes.N/AApproved In ProgressPharma01) Intimation/Approval will be submitted. RA 02) Development and approval of artwork. BD 03) Item code will be opened. BD 04) Consumption of old inventory SCM 05) First consignment of new DI availability as per new item code. SCM 06) BOM will be revised as per new item code. (QA) 07) Specification will be Revised. QC Timelines for each component is different and mentioned in the attached excel sheet 16/09/202418/11/2024Hamza Ahmed Hamza Ahmed
CMP-0129-2416/09/2024Medical Affairs Permanent MinorChange in PIL of Inosita XR plusDeficient information in the following headings: 1. Contraindications 2. Warning and precautions 3. ADRsCONTRAINDICATIONS: breast-feeding. serum creatinine levels greater than or equal to 1.5 mg/dL for men, greater than or equal to 1.4 mg/dL for women or abnormal creatinine clearance. WARNING AND PRECAUTIONS: Hypoglycemia: Hypoglycemia does not occur in patients receiving metformin alone under usual circumstances of use, but could occur when caloric intake is deficient, when strenuous exercise is not compensated by caloric supplementation, or during concomitant use with other glucose-lowering agents. ADVERSE REACTIONS: Blood and lymphatic system disorders: Rare: thrombocytopenia, Metabolism and nutrition disorders: Common: Vitamin B 12 decrease/deficiency. Nursing mothers: Janumet must therefore not be used in women who are breast-feeding. N/AApproved In ProgressPharma01) Intimation/Approval will be submitted. RA 02) Development and approval of artwork. BD 03) Item code will be opened. BD 04) Consumption of old inventory SCM 05) First consignment of new DI availability as per new item code. SCM 06) BOM will be revised as per new item code. (QA) 07) Specification will be Revised. QC Timelines for each component is different and mentioned in the attached excel sheet 16/09/202418/11/2024Hamza Ahmed Hamza Ahmed
CMP-0130-2416/09/2024Medical Affairs Permanent MinorChange in PIL of Byvas• Some informations regarding contraindicaton, warning and precaution, ADRs, & use in special population is missing. • Additional information in PIL that no longer exist in FDA or EMA1. CONTRAINDICATIONS: - hypotension (systolic blood pressure< 90 mmHg). 2.WARNING AND PRECAUTIONS: • Use with CYP2D6 Inhibitors: Nebivolol exposure increases with inhibition of CYP2D6 [see Drug Interactions (7)]. The dose of BYSTOLIC may need to be reduced. • Cardiovascular: In general, beta-adrenergic antagonists should not be used in patients with untreated congestive heart failure (CHF), unless their condition has been stabilized. 3.ADVERSE REACTIONS Metabolic and Nutritional Disorders: hypercholesterolemia: Skin and subcutaneous tissue disorders: NOT KNOWN: Urticaria 4.USE IN SPECIAL POPULATIONS: HEART FAILURE: no worsening of heart failure was reported with nebivolol compared to placebo. However, if heart failure worsens consider discontinuation of BYSTOLIC. *ADDITIONAL INFORMATION WRITTEN IN PIL OF PHARMEVO WHICH IS NEITHER PRESENT IN FDA NOR IN EMA • Not known: Insomnia • Not known: somnolence, vertigo • Not known: atrioventricular block (both second and third degree), myocardial infarction, peripheral ischemia/claudication N/AApproved In ProgressPharma01) Intimation/Approval will be submitted. RA 02) Development and approval of artwork. BD 03) Item code will be opened. BD 04) Consumption of old inventory SCM 05) First consignment of new DI availability as per new item code. SCM 06) BOM will be revised as per new item code. (QA) 07) Specification will be Revised. QC Timelines for each component is different and mentioned in the attached excel sheet 16/09/202418/11/2024Hamza Ahmed Hamza Ahmed
CMP-0131-2416/09/2024Medical Affairs Permanent MinorChange in PIL of XilicaAddition of content required in description, indications, dosage and administration, ADRs, warning and precautions, & use in special population1.DESCRIPTION: and the molecular weight is 159.23 2.INDICATIONS: 4 years of age and older. 3.DOSAGE AND ADMINISTRATION: • Epilepsy: Pregabalin treatment can be started with a dose of 150 mg per day given as two or three divided doses. Based on individual patient response and tolerability, the dose may be increased to 300 mg per day after 1 week. The maximum dose of 600 mg per day may be achieved after an additional week. • Generalised anxiety disorder: The dose range is 150 to 600 mg per day given as two or three divided doses. The need for treatment should be reassessed regularly. • Neuropathic Pain Associated with Diabetic Peripheral Neuropathy in Adults: if needed, to a maximum dose of 600 mg per day after an additional 7-day interval. Adjunctive Therapy for Partial-Onset Seizures: 4 years of age and older, 11 kg to less than 30 kg . 4.WARNING &PRECAUTIONS: Hypersensitivity reactions: Adverse reactions included skin redness, blisters, hives, rash, dyspnea, and wheezing. 5.ADVERSE REACTIONS: • Hepatobiliary disorders Uncommon Elevated liver enzymes*, Rare Jaundice, Very rare Hepatic failure, hepatitis • Psychiatric disorders: Rare: suicidal behavior, suicidal ideation. • Nervous system disorders: Rare: parkinsonism • Skin and subcutaneous tissue disorders: Rare: Toxic epidermal necrolysis 6.USE IN SPECIAL POPULATION: Adjunctive Therapy for Partial-Onset Seizures: The safety and effectiveness of LYRICA as adjunctive treatment for partial onset seizures in pediatric patients 4 to less than 17 years of age have been established. N/AApproved In ProgressPharma01) Intimation/Approval will be submitted. RA 02) Development and approval of artwork. BD 03) Item code will be opened. BD 04) Consumption of old inventory SCM 05) First consignment of new DI availability as per new item code. SCM 06) BOM will be revised as per new item code. (QA) 07) Specification will be Revised. QC Timelines for each component is different and mentioned in the attached excel sheet 16/09/202418/11/2024Hamza Ahmed Hamza Ahmed
CMP-0132-24 18/09/2024Product DevelopmentPermanent MajorNew product launch vonoprazan 10mg and 20mgProduct development activities of the generic vonoprazan 10mg and 20mg tablets have been completed. It is proposed to commercialize the vonoprazan 10mg and 20mg tablets in pharm Evo facility. RA-0035-24Approved30/04/2025In ProgressPharma1) PD trial required with stability report. PD 2) Cleanability report required. PD 3) Technology transfer protocol (for process) is required. PD 4) Technology transfer protocol (for analytical testing) is required. PD 5) Registration letter is required. RA 6) Raw material codes will be opened. SCM 7) Approved artwork will developed. BD 8) Packaging material codes will be opened. BD 9) Analytical testing method will prepared and update on LIMS. QC 10) Method Verification is required. QC 11) Specifications will be developed and update on LIMS. QC 12) Batch documents (BDR, BMR, BYS, BPR) will prepare. QA 13) Planning of product launch for commercial. BD 14) Process validation will be perform. QA-VAL 15) Product will be charge on stability. QC 1) Done 2) Oct-24 3) Oct-24 4) Oct-24 5) Oct-24 6) Done 7) Oct-24 8) Oct-24 9) Oct-24 10) Oct-24 11) Feb-25 12) Jan-25 13) Jan-25 14) July-25 15) July-25 18/09/202418/11/2024Hamza Ahmed Hamza Ahmed
CMP-0133-24 20/09/2024Product DevelopmentPermanent  Increase in batch size of Aprep 80mg Capsule and Combo pack of Aprep 80mg and Aprep 125mg Capsule1) Currently Aprep 80mg Capsule and 125mg Capsule is packed in 2's and 1's blister respectively in separate unit carton. 2) Batch size of Aprep 80mg Capsule is 8000 Capsules.1) It is proposed to pack in a single unit carton as a combo pack containing one blister of 2 Capsules of Aprep 80mg and one blister of 1 Capsule of Aprep 125mg. 2) Proposed batch size for Aprep 125mg Capsule is 16000.RA-0034-24under Approval  Pharma 20/09/202428/09/2024Hamza Ahmed Hamza Ahmed
CMP-0134-24 20/09/2024Product DevelopmentPermanent MajorNew product launch Cholestyramine 4mg Sachet Product development activities of the following generic have been developed. . Cholestyramine 4mg Sachet It is proposed to commercialize the following generic in pharm Evo facility. . Cholestyramine 4mg Sachet RA-0035-24Approved31/01/2025 Pharma 1) PD trial required with stability report. PD 2) Cleanability report required. PD 3) Technology transfer protocol (for process) is required. PD 4) Technology transfer protocol (for analytical testing) is required. PD 5) Registration letter is required. RA 6) Raw material codes will be opened. SCM 7) Approved artwork will developed. BD 8) Packaging material codes will be opened. BD 9) Analytical testing method will prepared and update on LIMS. QC 10) Method Verification is required. QC 11) Specifications will be developed and update on LIMS. QC 12) Batch documents (BDR, BMR, BYS, BPR) will prepare. QA 13) Planning of product launch for commercial. BD 14) Process validation will be performed. QA-VAL 15) Product will be charge on stability. QC 1) Done 2) Oct-24 3) Oct-24 4) Oct-24 5) Oct-24 6) Done 7) Oct-24 8) Oct-24 9) Nov-24 10) Nov-24 11) Dec-24 12) Dec-24 13) Dec-2414) Apr-25 15) Apr-25 20/09/202426/10/2024Hamza Ahmed Hamza Ahmed
CMP-0135-24 23/09/2024QCPermanent MinorInstallation of TOC auto sampler in QC laboratoryCurrently we have TOC instrument in QC lab(Non-Ceph), in which one sample can be injected at a time by using one injection probe(Tube).Now it is proposed to procure auto sampler for TOC. N/AApproved30/09/2024In ProgressPharma1) Equipment Qualification will be performed. 2) SOP of TOC analyzer will be revised. 3) Training will be provided to concern staff. 1) Sep-24 2) Sep-24 3) Sep-24 23/09/202428/10/2024Hamza Ahmed Hamza Ahmed
CMP-0136-24 24/09/2024BDPermanent MajorNew products launch in Afghanistan.The below-mentioned products are not launched in Afghanistan yet. 1 AirCare Plus DPI Device 2 Busonide DPI 200/6mcg Capsule 3 Busonide DPI 400/12mcg Capsule 4 Tiocap DPI 18mcg Capsule It is proposed to launch these products in Afghanistan.N/AApproved31/10/2024In ProgressPharma1) Product launch in Afghanistan. 2) FG codes will be opened. 3) BOM will create on SAP. 4) BPR will be prepared. 1) Oct-24 2 ) Oct-24 3) Oct-24 4) Oct-24 24/09/202426/10/2024Hamza Ahmed Hamza Ahmed
CMP-0137-24 24/09/2024SCMPermanent  Additional source induction of LinagliptinWe have approved sources for Linagliptin as M/s JIANGSU YONGAN & M/s. Lee Pharma Limited.We intend to induct one more source M/s. Shandong XierKangtai Pharmaceutical Co., Ltd.. Address: Private Industrial Zone of Xinyan Town, Yanzhou District, Jining City, Shandong Province, China. N/Aunder Approval  Pharma 24/09/2024 Hamza Ahmed  
CMP-0138-24 26/09/2024BDPermanent MinorNew products launch in IRAQThe below mentioned products are not launched in Iraq yet. 1. Telsarta-A 5/80mg Tablet 2. Utfix 0.4mg CapsuleIt is proposed to launch these products in Iraq.N/AApproved31/01/2025In ProgressPharma1) Registration Letter required RA 2) Product launch in IRAQ. BD 3) Development and approval of artwork BD 4) Item code will open for new developed artwork QC 5) FG codes will be opened SCM 6) Specification will be updated QC 7) EPO instructions required. BD 8) BOM will create on SAP QA 9) BPR will be prepared QA 1) Registered 2) Jan-25 3) Oct-24 4) Oct-24 5) Oct-24 6) Jan-25 7) Oct-24 8) Dec-24 9) Dec-24 26/09/202426/10/2024Hamza Ahmed Hamza Ahmed
CMP-0139-2426/09/2024MarketingPermanent MinorChange in unit carton of Evo pride 2mg Vietnam We are supplying below mentioned product in Vietnam without importer details: 1. Evopride 2mg Tablet Partner distributor has requested to in-cooperate the details of the importer on Unit Carton 1. Evopride 2mg Tablet (Detail attached)N/AApproved31/12/2024In ProgressPharma1. Development and approval of artwork. BD 2. Item code will open for new developed artwork. BD 3. Availability of new unit cartons. SCM 4. Specification will be updated. QC PKG 5. BOM will be updated. QA 1) Done 2) Done 1) Already Done 2) Already Done 3) Nov-24 4) Nov-24 5) Nov-24 26/09/202418/11/2024Hamza Ahmed Hamza Ahmed
CMP-0140-24 28/09/2024QCPermanent MinorTo revise the method of hydrochlorothiazide 0document no ACTM 1017 version no 04 according with the current USP-43 monograph.Currently, the LIMS and testing methods are aligned with the previous version of the USP-42.It is proposed to revise the testing method and LIMS specification for hydrochlorothiazide according to the current USP-43.N/AApproved30/09/2024In ProgressPharma1) Testing methos will be revised. QC 2) LIMS specification will be updated. QC 1) Sep-24 2) Sep-24 28/09/202428/10/2024Hamza Ahmed Hamza Ahmed
CMP-0141-24 01/10/2024QCPermanent  Addition of new Dissolution apparatus in QC LabCurrently we have following quantities of Dissolution apparatus for Raw material, Finished product and Stability testing. Instrument &make Qty 1) Dissolution Apparatus (06) (Pharma test) It is proposed that following instrument will be installed in QC Laboratory. Instrument &make Qty 1) Dissolution Apparatus (01) (Pharma test) N/Aunder Approval  Pharma 01/10/2024 Hamza Ahmed  
CMP-0142-24 01/10/2024QCPermanent  Addition of new HPLC in QC LabCurrently we have following quantities of HPLC for Raw material, Finished product and Stability testing. Instrument &make Qty 1) HPLC(Shimadzu) 07 2) HPLC(Agilent) 05 3) HPLC(Thermo) 02 It is proposed that following instruments will be installed in QC Laboratory. Instrument &make Qty 1) HPLC(Shimadzu) 07 2) HPLC(Thermo) 03 N/Aunder Approval  Pharma 01/10/2024 Hamza Ahmed  
CMP-0143-24 02/10/2024QCPermanent  To create the quick access form QC to general offices and vice versaThe current QC laboratory and general offices(QA, RA, SCM) are located on same floor(1st Floor) but there is no provision of movement form QC to general offices and vice versa on 1st floor.It is proposed to crearte the entrance room in QC for quick access from QC laboratory to general offices and vice versa. This provision will be created through change room for gowning/degowning.N/Aunder Approval  Pharma 02/10/202402/10/2024Hamza Ahmed Hamza Ahmed
CMP-0144-24 02/10/2024Product DevelopmentPermanent MajorNew product launch Linagliptin 5mg TabletProduct development activities of Linagliptin 5mg tablet has been completed.It is proposed to commercialize the Linagliptin 5mg tablet in pharm Evo facility. This product will be launched in IraqN/AApproved31/08/2025In ProgressPharma1) PD trial required with stability report. PD 2) Cleanability report required. PD 3) Technology transfer protocol (for process) is required. PD 4) Technology transfer protocol (for analytical testing) is required. PD 5) Registration letter is required. RA 6) Raw material codes will be opened. SCM 7) Approved artwork will developed. BD 8) Packaging material codes will be opened. BD 9) Analytical testing method will prepared and update on LIMS. QC 10) Specifications will be developed and update on LIMS. QC 11) Batch documents (BDR, BMR, BYS, BPR) will prepare. QA 12) Planning of product launch for commercial. BD 13) Process validation will be perform. QA-VAL 14) Product will be charge on stability. QC 15) Special import permit is required for IRAQ. BD 1) Done 2) Done 3) Dec-24 4) Dec-24 5) Registered 6) Done 7) Oct-24 8) Oct-24 9) Dec-24 10) Jan-25 11) Jan-25 12) Jan-25 13) Aug-25 14) Aug-25 15) Jan-25 02/10/202428/10/2024Hamza Ahmed Hamza Ahmed
CMP-0145-24 02/10/2024Bussiness DevelopmentPermanent MinorLaunch of Klevra(Levetiracetam) 500mg Tablet in pack size of 100's in Philippines.This product is only available in pack sizes of 30's and 90's in Philippines.The product Klevra(Levetiracetam)500mg Tablets will be launched in additional pack size of 100's in Philippines.N/AApproved31/03/2025In ProgressPharma1) Registration Letter required RA 2) Product launch in Philippines. BD 3) Development and approval of artwork BD 4) Item code will open for new developed artwork QC 5) FG codes will be opened SCM 6) Specification will be updated QC 7) BOM will create on SAP QA 8) BPR will be prepared QA 1) Feb-25 2) Mar-25 3) Feb-25 4) Nov-24 5) Oct-24 6) Mar-25 7) Feb-25 8) Feb-25 02/10/202413/11/2024Hamza Ahmed Hamza Ahmed
CMP-0146-24 04/10/2024BDPermanent MinorLaunch of New Products in Azerbaijan.The products mentioned in the attached list are not launched in Azerbaijan yet.These products are planned for launch in Azerbaijan.N/AApproved31/03/2025In ProgressPharmaAction plan will remain same for all the products. 1) Registration Letter required RA 2) Product launch in Azerbaijan. BD 3) Development and approval of artwork BD 4) Item code will open for new developed artwork QC 5) FG codes will be opened SCM 6) Specification will be updated QC 7) BOM will create on SAP QA 8) BPR will be prepared QA 9) Shelf life for export product list will be updated. QA Timelines are same for the Redexa 60mg Cap & Erli Plus XR 12.5/1000mg Tab: 1) Nov-24 2) Dec-24 3) Nov-24 4) Nov-24 5) Nov-24 6) Dec-24 7) Dec-24 8) Dec-24 9) Dec-24 Timelines for Bongard 70mg tablet: 1) Jan-25 2) Feb-25 3) Nov-24 4) Nov-24 5) Nov-24 6) Feb-25 7) Jan-25 8) Jan-25 9) Jan-25 Timelines are same for setspin 16mg & Setspin 24mg Tab: 1) Mar-25 2) Apr-25 3) Nov-24 4) Nov-24 5) Nov-24 6) Apr-25 7) Mar-25 8) Mar-25 9) Mar-25 07/10/202426/10/2024Hamza Ahmed Hamza Ahmed
CMP-0147-24 04/10/2024BDPermanent MinorLaunch of New Products in Uzbekistan.The products mentioned in the attached list are not launched in Uzbekistan yet.These products are planned for launch in Uzbekistan.N/AApproved31/03/2025In ProgressPharmaAction plan will remain same for all the products. 1) Registration Letter required RA 2) Product launch in Uzbekistan. BD 3) Development and approval of artwork BD 4) Item code will open for new developed artwork QC 5) FG codes will be opened SCM 6) Specification will be updated QC 7) BOM will create on SAP QA 8) BPR will be prepared QA 9) Shelf life for export product list will be updated. QA Timelines are same for the Erli 10mg Tab, Xcept 10mg Tab, Xcept 15mg Tab, Xcept 20mg Tab, Anplag 90mg Tab: 1) Jan-25 2) Jan-25 3) Nov-24 4) Nov-24 5) Nov-24 6) Jan-25 7) Jan-25 8) Jan-25 9) Jan-25 Timelines are line for Inosita Plus 50/500mg Tab & Inosita Plus 50/1000mg tablet: 1) Registered 2) Jan-25 3) Nov-24 4) Nov-24 5) Nov-24 6) Jan-25 7) Jan-25 8) Jan-25 9) Jan-25 Timelines for Avsar 80/5mg Tab & Avsar 160/5mg Tab & Avsar 160/10mg Tab: 1) Mar-25 2) Jun--25 3) Nov-24 4) Nov-24 5) Nov-24 6) Jan-25 7) Jun-25 8) Jun--25 9) Jun--25 07/10/202412/11/2024Hamza Ahmed Hamza Ahmed
CMP-0148-24 04/10/2024BDPermanent MinorLaunch of New Products in Uganda.The products mentioned in the attached list are not launched in Uganda yet.These products are planned for launch in Uganda.N/AApproved31/01/2025In ProgressPharmaAction plan will remain same for all the products. 1) Registration Letter required RA 2) Product launch in Uganda. BD 3) Development and approval of artwork BD 4) Item code will open for new developed artwork QC 5) FG codes will be opened SCM 6) Specification will be updated QC 7) BOM will create on SAP QA 8) BPR will be prepared QA 9) Shelf life for export product list will be updated. QA Timelines for product Glavecta Plus 50/1000mg Tab: 1) Mar-25 2) Apr-25 3) Nov-24 4) Nov-24 5) Nov-24 6) Apr-25 7) Apr-25 8) Apr-25 9) Jun-25 Timelines for remaining products are: 1) Mar-25 2) Apr-25 3) Nov-24 4) Nov-24 5) Nov-24 6) Apr-25 7) Mar-25 8) Mar-25 9) Apr-25 07/10/202413/11/2024Hamza Ahmed Hamza Ahmed
CMP-0149-24 04/10/2024SCMPermanent MinorChange in Manufacturer name of M/s Aurobindo Pharma LimitedWe have approved MANUFACTURER by the name of M/s Aurobindo Pharma Limited, for APIs listed in Vendor List . Address: Unit 1: Survey No.379, 385, 386, 388 to 396, Borpatla (Village), Hatnoora (Mandal), Sanga Reddy (District), Telangana (State), INDIA. PIN: 502 296. This is to inform you that M/s Aurobindo Pharma Limited has merged its API business with Apitoria Pharma Private Limited and New Name of manufacturer will be Apitoria Pharma Private Limited while manufacturing site address will be remain same. New Supplier SAP CODE WILL OPENED.N/AApproved In ProgressPharma1) New supplier code will be opened. SCM 2) Existing supplier code will get inactive. 3) Vendor list will be updated based on receiving batch documents. QA 4) LIMS will be updated with new manufacturer name. QC 5) Administrative documents will be submitted to QA. SCM 1) SCM 2) SCM 3) QA 4) QC 5) SCM 07/10/202430/10/2024Hamza Ahmed Hamza Ahmed
CMP-0150-24 04/10/2024BDPermanent MinorLaunch of New Products in Sri Lanka.The products mentioned in the attached list are not launched in Sri Lanka yet.These products are planned for launch in Sri Lanka.N/AApproved31/03/2025In ProgressPharmaAction plan will remain same for all the products except Arbi-H 300/25mg Tab: 1) Registration Letter required RA 2) Product launch in Sri Lanka. BD 3) Development and approval of artwork BD 4) Item code will open for new developed artwork QC 5) FG codes will be opened SCM 6) Specification will be updated QC 7) BOM will create on SAP QA 8) BPR will be prepared QA 9) Shelf life for export product list will be updated. QA Action plan Arbi-H 300/25mg Tab: 1) Registration Letter required RA 2) Product launch in Sri Lanka. BD 3) Development and approval of artwork BD 4) Item code will open for new developed artwork QC 5) FG codes will be opened SCM 6) Specification will be updated QC 7) BOM will create on SAP QA 8) BPR will be prepared QA 9) Shelf life for export product list will be updated. QA 10) Blister tooling is required. Production Timelines for Ivadin 05mg tablet: 1) Jan-25 2) Feb-25 3) Nov-24 4) Nov-24 5) Nov-24 6) Feb-25 7) Feb-25 8) Feb-25 9) Feb-25 Timelines are same for Erlina 10/5mg Tab, Erlina 25/5mg tab, Erli Plus 12.5/500mg Tab, Erli Plus 12.5/850mg Tab, Erli Plus 5/850mg Tab, Arbi-H 150/12.5mg Tab, Arbi-H 150/12.5mg Tab, Galvecta 50mg Tab & Galvecta plus 50/850mg Tab: 1) Mar-25 2) Apr-25 3) Nov-24 4) Nov-24 5) Nov-24 6) Apr-25 7) Mar-25 8) Mar-25 9) Mar-25 Timeline for the Arbi-H 300/25mg Tab: 1) Mar-25 2) Apr-25 3) Nov-24 4) Nov-24 5) Nov-24 6) Apr-25 7) Mar-25 8) Mar-25 9) Mar-25 10) Jan-25 07/10/202412/11/2024Hamza Ahmed Hamza Ahmed
CMP-0151-24 04/10/2024QCPermanent  Update the approval process of testing method (from manager QC to head QO)Currently SOP’s of Quality control approved by head QO but testing method Specification of finish good, raw materials and packaging materials approved by Quality Control Manager.It is proposed that all testing method specification of finish good, raw materials and packaging materials will be approved by Quality Operations Head.N/Aunder Approval  Pharma 07/10/202409/10/2024Hamza Ahmed Hamza Ahmed
CMP-0152-24 04/10/2024BDPermanent MinorLaunch of Presuvas Tablets 10mg (10x10’s) in Philippines.This product is not launched in Philippines yet.The product Presuvas (Rosuvastatin) Tablets 10mg (10x10’s) is planned for launch in Philippines.N/AApproved31/01/2025In ProgressPharma1) Registration Letter required RA 2) Product launch in Philippines. BD 3) Development and approval of artwork BD 4) Item code will open for new developed artwork QC 5) FG codes will be opened SCM 6) Specification will be updated QC 7) BOM will create on SAP QA 8) BPR will be prepared QA 9) Shelf life for export product list will be updated. QA 1) Registered 2) Jan-25 3) Nov-24 4) Nov-24 5) Oct-24 6) Jan-25 7) Dec-24 8) Dec-24 9) Dec-24 07/10/202426/10/2024Hamza Ahmed Hamza Ahmed
CMP-0153-24 04/10/2024BDPermanent MinorLaunch of New Products in Nicaragua.The products mentioned in the attached list are not launched in Nicaragua yet.These products are planned for launch in Nicaragua.N/AApproved31/05/2025In ProgressPharmaAction plan are same for all the products except Arbi-D 300/25mg Tab: 1) Registration Letter required RA 2) Product launch in Nicaragua. BD 3) Development and approval of artwork BD 4) Item code will open for new developed artwork QC 5) FG codes will be opened SCM 6) Specification will be updated QC 7) BOM will create on SAP QA 8) BPR will be prepared QA 9) Shelf life for export product list will be updated. QA Timelines are same for all the products 1) Feb-25 2) May-25 3) Dec-24 4) Dec-24 5) Dec-24 6) May-25 7) Apr-25 8) Apr-25 9) Apr-25 07/10/202426/10/2024Hamza Ahmed Hamza Ahmed
CMP-0154-24 04/10/2024BDPermanent MinorLaunch of New Products in Maldives.The products mentioned in the attached list are not launched in Maldives yet.These products are planned for launch in Maldives.N/AApproved31/03/2025In ProgressPharmaAction plan are same for all the products except Arbi-D 300/25mg Tab: 1) Registration Letter required RA 2) Product launch in Maldives. BD 3) Development and approval of artwork BD 4) Item code will open for new developed artwork QC 5) FG codes will be opened SCM 6) Specification will be updated QC 7) BOM will create on SAP QA 8) BPR will be prepared QA 9) Shelf life for export product list will be updated. QA Timelines are same for Aireez 10mg Tab,Avsar 80/05mg Tab, Evofix Suspension 60ml & Avsar 160/10mg Tab: 1) Registered 2) Mar-25 3) Nov-24 4) Nov-24 5) Dec-24 6) Mar-25 7) Feb-25 8) Feb-25 9) Feb-25 Timelines are same for the remaining products in the list: 1) Mar-25 2) Mar-25 3) Nov-24 4) Nov-24 5) Dec-24 6) Mar-25 7) Feb-25 8) Feb-25 9) Feb-25 07/10/202412/11/2024Hamza Ahmed Hamza Ahmed
CMP-0155-2404/10/2024BDPermanent MinorLaunch of New Products in Kosovo.The products mentioned in the attached list are not launched in Kosovo yet.These products are planned for launch in Kosovo.N/AApproved30/04/2025In ProgressPharma1) Registration Letter required RA 2) Product launch in Kosovo. BD 3) Development and approval of artwork BD 4) Item code will open for new developed artwork QC 5) FG codes will be opened SCM 6) Specification will be updated QC 7) BOM will create on SAP QA 8) BPR will be prepared QA 9) Shelf life for export product list will be updated. QA Timelines are same for all products: 1) Mar-25 2) Apr-25 3) Nov-24 4) Nov-24 5) Dec-24 6) Apr-25 7) Apr-25 8) Apr-25 9) Apr-25 07/10/202428/10/2024Hamza Ahmed Hamza Ahmed
CMP-0156-2404/10/2024BDPermanent MinorLaunch of New Products in Kenya.The products mentioned in the attached list are not launched in Kenya yet.These products are planned for launch in Kenya.N/AApproved30/06/2025In ProgressPharmaAction plan are same for all the products except Arbi-D 300/25mg Tab: 1) Registration Letter required RA 2) Product launch in Maldives. BD 3) Development and approval of artwork BD 4) Item code will open for new developed artwork QC 5) FG codes will be opened SCM 6) Specification will be updated QC 7) BOM will create on SAP QA 8) BPR will be prepared QA 9) Shelf life for export product list will be updated. QA Timelines for Feboxin 40mg Tab & Feboxin 80mg Tab: 1) Registered 2) Dec-24 3) Nov-24 4) Nov-24 5) Nov-24 6) Dec-24 7) Dec-24 8) Dec-24 9) Dec-24 Timelines for the remaining products are: 1) Feb-25 2) Jun-25 3) Nov-24 4) Nov-24 5) Oct-24 6) Jun-25 7) Jun-25 8) Jun-25 9) Jun-25 07/10/202413/11/2024Hamza Ahmed Hamza Ahmed
CMP-0157-2404/10/2024BDPermanent  Launch of New Products in Iraq.The products mentioned in the attached list are not launched in Iraq yet.These products are planned for launch in Iraq.N/Aunder Approval  Pharma 07/10/2024 Hamza Ahmed  
CMP-0158-2404/10/2024BDPermanent MinorLaunch of New Products in Honduras.The products mentioned in the attached list are not launched in Honduras yet.These products are planned for launch in Honduras.N/AApproved31/03/2025In ProgressPharma1) Registration Letter required RA 2) Product launch in Philippines. BD 3) Development and approval of artwork BD 4) Item code will open for new developed artwork QC 5) FG codes will be opened SCM 6) Specification will be updated QC 7) BOM will create on SAP QA 8) BPR will be prepared QA 9) Shelf life for export product list will be updated. QA Timelines for Bandro 150mg Tab: 1) Registered 2) Jan-25 3) Nov-24 4) Nov-24 5) Nov-24 6) Jan-25 7) Dec-24 8) Dec-24 9) Dec-24 Timelines for the remaining products are: 1) Dec-24 2) Mar-25 3) Nov-24 4) Nov-24 5) Nov-24 6) Mar-25 7) Feb-24 8) Feb-24 9) Feb-24 07/10/202426/10/2024Hamza Ahmed Hamza Ahmed
CMP-0159-2404/10/2024BDPermanent MinorLaunch of New Products in Guatemala.The products mentioned in the attached list are not launched in Guatemala yet.These products are planned for launch in GuatemalaN/AApproved31/08/2025In ProgressPharmaAction plan will remain same for all the products. 1) Registration Letter required RA 2) Product launch in Guatemala. BD 3) Development and approval of artwork BD 4) Item code will open for new developed artwork QC 5) FG codes will be opened SCM 6) Specification will be updated QC 7) BOM will create on SAP QA 8) BPR will be prepared QA 9) Shelf life for export product list will be updated. QA Timelines for zibes 10mg Tablet: 1) Nov-24 2) Aug-25 3) Nov-24 4) Nov-24 5) Oct-24 6) Aug-25 7) July-25 8) July-25 9) July-25 Timelines for Anex-M Tablet: 1) July-25 2) Aug-25 3) July-25 4) July-25 5) Oct-24 6) Aug-25 7) July-25 8) July-25 9) July-25 Timelines for Erlina 10/5mg and Erlina 25/5mg tablet are same: 1) Mar-25 2) Aug-25 3) Mar-25 4) Mar-25 5) Oct-24 6) Aug-25 7) July-25 8) July-25 9) July-25 07/10/202428/10/2024Hamza Ahmed Hamza Ahmed
CMP-0160-2404/10/2024BDPermanent MinorLaunch of New Products in Ghana.The products mentioned in the attached list are not launched in Ghana yet.These products are planned for launch in Ghana.N/AApproved28/02/2025In ProgressPharmaAction plan are same for all the products except Arbi-D 300/25mg Tab: 1) Registration Letter required RA 2) Product launch in Ghana. BD 3) Development and approval of artwork BD 4) Item code will open for new developed artwork QC 5) FG codes will be opened SCM 6) Specification will be updated QC 7) BOM will create on SAP QA 8) BPR will be prepared QA 9) Shelf life for export product list will be updated. QA Timelines are same for all the products. 1) Jan-25 2) Feb-25 3) Dec-24 4) Dec-24 5) Nov-24 6) Feb-25 7) Feb-25 8) Feb-25 9) Feb-25 07/10/202401/11/2024Hamza Ahmed Hamza Ahmed
CMP-0161-2404/10/2024SCMPermanent Minor: Additional source induction of Croscarmellose Sodium, Microcrystalline Cellulose PH101 & PH102We are currently procuring Excipient: Croscarmellose Sodium from M/s. Ashland & M/s. Boai NKY Medical Holdings Ltd and Microcrystalline Cellulose PH101 & PH102 from M/s. Hunan Jiudian Hongyang Pharmaceutical Co Ltd & Mingtai Chemicals.We intend to induct one more source M/s. NITIKA PHARMACEUTICAL SPECIALITIES PVT. LTD, Address: Block no. 3 of plot no. 1296, 1297/08, ward no 03,, mouzawaddhamna, amravati road, nagpur - 440023 , dist - nagpur zone 1, India.N/AApproved In ProgressPharmaAction plans are same for all excipients. 1) Source approval documents will be required. SCM 2) Approved vendor list will be required. QA 3) New source name will be updated in LIMS. QC 1) Dec-2024 2) Apr-25 07/10/202430/10/2024Hamza Ahmed Hamza Ahmed
CMP-0162-2404/10/2024BDPermanent MinorLaunch of New Products in El Salvador.The products mentioned in the attached list are not launched in El Salvador yet.These products are planned for launch in El Salvador.N/AApproved31/03/2025In ProgressPharmaAction plan will remain same for all the products except Arbi-D 300/25mg Tab: 1) Registration Letter required RA 2) Product launch in Sri Lanka. BD 3) Development and approval of artwork BD 4) Item code will open for new developed artwork QC 5) FG codes will be opened SCM 6) Specification will be updated QC 7) BOM will create on SAP QA 8) BPR will be prepared QA 9) Shelf life for export product list will be updated. QA Timelines for Byvas 5mg Tablet and Emglin 25mg Tablet are same: 1) Registered 2) Jan-25 3) Nov-24 4) Nov-24 5) Nov-24 6) Jan-25 7) Jan-25 8) Jan-25 9) Jan-25 Timelines for Evofix 100mg/5ml suspension are: 1) Dec-24 2) Jan-25 3) Nov-24 4) Nov-24 5) Nov-24 6) Jan-25 7) Jan-25 8) Jan-25 9) Jan-25 Timelines for Evofix 400mg Cap (10's), Evofix 400mg Cap (5's), Inosita Plus 50/1000mg Tablet, Inosita Plus 50/500mg Tablet, Redexa 30mg Cap, Redexa 60mg Cap, Trixafin 1g IM Injection, Vonevo 10mg Tablet, Vonevo 20mg Tablet are same: 1) Dec-24 2) Jun-25 3) Nov-24 4) Nov-24 5) Nov-24 6) Jun-25 7) Jun-25 8) Jun-25 9) Jun-25 Timelines for Bandrio 150mg Tab, Floractiva 250mg Sac, Inuric-G 80mg Tab, Nuval Compositum 160/10mg, Trixafin 1g IV Inj and X-plended 20mg Tab: 1) Dec-24 2) Mar-25 3) Nov-24 4) Nov-24 5) Nov-24 6) Mar-25 7) Mar-25 8) Mar-25 9) Mar-25 07/10/202428/10/2024Hamza Ahmed Hamza Ahmed
CMP-0163-2404/10/2024BDPermanent MinorLaunch of New Products in Cambodia.The products mentioned in the attached list are not launched in Cambodia yet.These products are planned for launch in Cambodia.N/AApproved31/05/2025In ProgressPharmaAction plan will remain same for all the products except Arbi-D 300/25mg Tab: 1) Registration Letter required RA 2) Product launch in Sri Lanka. BD 3) Development and approval of artwork BD 4) Item code will open for new developed artwork QC 5) FG codes will be opened SCM 6) Specification will be updated QC 7) BOM will create on SAP QA 8) BPR will be prepared QA 9) Shelf life for export product list will be updated. QA Timelines for Dapwiz 10mg tablet and Erli 25mg tablet are same: 1) Jan-25 2) Feb-25 3) Nov-24 4) Nov-24 5) Dec-24 6) Dec-24 7) Dec-24 8) Dec-24 9) Dec-24 Timelines are same for Erlina Plus XR 10/1000mg Tab and Erli Plus XR 25/1000mg tab: 1) May-25 2) Jun-25 3) Nov-24 4) Nov-24 5) Dec-24 6) Jun-25 7) Jun-25 8) Jun-25 9) Jun-25 Timelines for Dapwiz 5mg Tablet, Erli Plus 12.5/500mg Tab, Erli Plus 12.5/850mg Tab, Erli 10mg Tab, Xilica 100 Cap and Xilica 75mg Cap: 1) Feb-25 2) Mar-25 3) Nov-24 4) Nov-24 5) Dec-24 6) Mar-25 7) Mar-25 8) Mar-25 9) Mar-25 07/10/202428/10/2024Hamza Ahmed Hamza Ahmed
CMP-0164-2407/10/2024QC MicroPermanent MajorInstallation of new autoclave in Non-Cephalosporin QC MicrolabCurrently, double door autoclave Jiangsu Shennong model YG-0.15 is used in non-cephalosporin Quality Control Microbiology Lab, for sterilization of media and dispose off waste.It is proposed to install another Autoclave Hiryama Model No. HV-110 Japan, in Non-Cephalosporin Quality Control Microbiology Lab for sterilization of media and accessories. Existing autoclave will be used for decontamination of waste.N/AApproved31/03/2025In ProgressPharma1) URS required of autoclave. Micro 2) IQ, OQ will be performed. Micro/Validation 3) PQ will be performed. Validation 4) SOP will be prepared. Micro 5) Training will be provided on SOP. Micro 6) Equipment will be part of PM plan. Engineering 1) Oct-24 2) Jan-25 3) Mar-25 4) Mar-25 5) Mar-25 6) Mar-25 07/10/202401/11/2024Hamza Ahmed Hamza Ahmed
CMP-0165-24 09/10/2024PDPermanent MajorNew launch of Bempedoic acid 180mg TabletProduct development activities of Bempedoic acid 180mg tablet has been completed.It is proposed to commercialize the Bempedoic acid 180mg tablet in pharm Evo facility. RA-0038-24Approved31/12/2025In ProgressPharma1) PD trial required with stability report. PD 2) Cleanability report required. PD 3) Technology transfer protocol (for process) is required. PD 4) Technology transfer protocol (for analytical testing) is required. PD 5) Registration letter is required. RA 6) Raw material codes will be opened. SCM 7) Approved artwork will developed. BD 8) Packaging material codes will be opened. BD 9) Analytical testing method will prepared and update on LIMS. QC 10) Specifications will be developed and update on LIMS. QC 11) Batch documents (BDR, BMR, BYS, BPR) will prepare. QA 12) Planning of product launch for commercial. BD 13) Process validation will be perform. QA-VAL 14) Product will be charge on stability. QC 15) Source approval documents are required. SCM 1) Done 2) Nov-24 3) Nov-24 4) Nov-24 5) Mar-25 6) Done 7) Nov-24 8) Nov-24 9) Mar-25 10) Mar-25 11) Mar-25 12) Mar-25 13) Dec-25 14) Dec-25 15) Nov-24 09/10/202428/10/2024Hamza Ahmed Hamza Ahmed
CMP-0166-2409/10/2024SCMPermanent  Release of Bisoprolol API having larger PSD results   under Approval  Pharma 09/10/2024 Hamza Ahmed  
CMP-0167-2414/10/2024ProductionPermanent  Transferring of products to Hoonga Blister machineThe Products mentioned on the attached list are currently being blistered on BM-350 as per mentioned dimensions(list attached).A/F 236mm & CFF 244mm.The Products mentioned on the attached list are agreed to move to the Hoonga Blister Machine as per mentioned dimensions(list attached). A/F 236mm & CFF 238mm. Dimensions of Unit Carton, Direction Insert & Master Carton will also be changed Accordingly. under Approval  Pharma 16/10/2024 Hamza Ahmed  
CMP-0168-24 15/10/2024ProductionPermanent  Implementation of Automation where Master Carton Labels will be directly printed from SAP system.Currently for labelling of Master cartons, manual labelling procedure is used. As per procedure of SOP PRG/2/035 a controlled format label is used in which batch information is filled for each batch at the time of usage and then affix them to the master carton using gum. It is proposed to implement master carton label through SAP. All the required information of batch will be automatically printed on labels. Self-adhesive white paper will be used for printing of labels under Approval  Pharma 16/10/2024 Hamza Ahmed  
CMP-0169-2415/10/2024PDPermanent MajorNew launch product Letrozole 2.5mg TabletCurrently, Letrozole tablet has been toll manufactured from radiant pharma.It is proposed to manufactured Letrozole 2.5mg Tablet in pharmevo facility. RA-0040-24Approved31/12/2025In ProgressPharma1) PD trial required with stability report. PD 2) Cleanability report required. PD 3) Technology transfer protocol (for process) is required. PD 4) Technology transfer protocol (for analytical testing) is required. PD 5) Registration letter is required. RA 6) Source approval documents will be submitted to QA. SCM. 7) Raw material codes will be opened. SCM 8) Approved artwork will developed. BD 9) Packaging material codes will be opened. BD 10) Analytical testing method will prepared and update on LIMS. QC 11) Specifications will be developed and update on LIMS. QC 12) Batch documents (BDR, BMR, BYS, BPR) will prepare. QA 13) Planning of product launch for commercial. BD 14) Process validation will be perform. QA-VAL 15) Product will be charge on stability. QC 15) Source approval documents are required. SCM 16) Acknowledgment of change of brand is required. 1) Done 2) Dec-24 3) Dec-24 4) Dec-24 5) Mar-25 6) Done 7) Done 8) Nov-24 9) Nov-24 10) Mar-25 11) Mar-25 12) Mar-25 13) Apr-25 14) Dec-25 15) Dec-25 16) Nov-24 16/10/202405/12/2024Hamza Ahmed Hamza Ahmed
CMP-0170-2415/10/2024QAPermanent  Proposal for Packaging Improvements of Trixafin Injection Shipment to AzerbaijanDuring the QA inspection of the first shipment to Azerbaijan, consisting of approximately 197,000 units of Trixafin Injection range, Below observations were noted in the packaging materials. These observations pose a risk to the product's integrity during transportation. Trixafin 1000mg Injection I.M.: Currently used unit carton is larger than the PVC tray. Existing dimensions of the cartons are 110x65x30mm. There is a risk of damage of Lidocaine Injection 2ml, due to inadequate tray size. Trixafin 500mg Injection I.M.: The master carton has a 2-inch space in both width and height. This creates a risk of damage (rattling, de-shaping, etc.). Shippers Packaging: The shipper carton also has a 2-inch space in both width and height. No separators or thermophore sheets are utilized to prevent rattling, deformation, and potential damage during transportation. Trixafin 1000mg Injection I.M: Reduce Trixafin 1g Unit carton dimensions upto 90x62x28mm for good fitting the PVC tray. The tray provides adequate support to injection vials and the Lidocaine Injection 2ml ampoules. Trixafin 500mg Injection I.M: Adjust the size of the master carton to eliminate the 2-inch excess space in both width and height. Consider introducing additional padding, fillers, or packing materials to stabilize the products within the carton. Shippers Packaging: Redesign the shipper cartons to eliminate the excess 2-inch space in both dimensions. Introduce separators or thermophore sheets between product layers within the shippers to minimize movement and prevent damage.  under Approval  Pharma 16/10/2024 Hamza Ahmed  
CMP-0171-2415/10/2024QAPermanent MajorRelease and disposition of Stevo tablets through quality inspection in SAP.Currently stevo tablets are released and dispatch by warehouse through GRN release process.It is proposed to change the process of product disposition and release of Stevo tablets through quality inspection in SAP.N/AApproved30/11/2024In ProgressPharma1) Inspection plan will be developed in SAP. QA 2) Quality Inspection check will be in-cooperate in SAP. WH 3) Testing method will be developed. QC 4) Specification will be added In LIMS. QC 5) SOP for “Management of Retention Samples” will be revised to in-cooperate the sampling criteria of Stevo tablets. QA 6) Samples will be submitted to QC for testing for each batch. QA 1) Nov-24 2) Nov-24 3) Nov-24 4) Nov-24 5) Nov-24 6) Nov-24 16/10/202402/11/2024Hamza Ahmed Hamza Ahmed
CMP-0172-2415/10/2024PDPermanent MajorNew Launch product Bempedoic acid/Ezetimibe 180/10mg TabProduct development activities of Bempedoic acid/Ezetimibe 180/10mg tablet has been completed.It is proposed to commercialize the Bempedoic acid/Ezetimibe 180/10mgtablet in pharm Evo facility.RA-0041-24Approved31/12/2025In ProgressPharma1) PD trial required with stability report. PD 2) Cleanability report required. PD 3) Technology transfer protocol (for process) is required. PD 4) Technology transfer protocol (for analytical testing) is required. PD 5) Registration letter is required. RA 6) Raw material codes will be opened. SCM 7) Approved artwork will developed. BD 8) Packaging material codes will be opened. BD 9) Analytical testing method will prepared and update on LIMS. QC 10) Specifications will be developed and update on LIMS. QC 11) Batch documents (BDR, BMR, BYS, BPR) will prepare. QA 12) Planning of product launch for commercial. BD 13) Process validation will be perform. QA-VAL 14) Product will be charge on stability. QC 15) Source approval documents are required. SCM 1) Done 2) Nov-24 3) Nov-24 4) Nov-24 5) Jan-25 6) Done 7) Dec-24 8) Nov-24 9) Dec-24 10) Jan-25 11) Jan-25 12) Jan-25 13) Aug-25 14) Aug-25 15) Nov-24 16/10/202428/10/2024Hamza Ahmed Hamza Ahmed
CMP-0173-2418/10/2024SCMTemporary Receiving of Levetiracetam QC Lot number 50576 & 50577 with smaller PSD value.Currently, in Levetiracetam (API) specification limit for PSD is (D90)= 300-600micron.We have received Levetiracetam (API) bacth number 50576 & 50577 approved manufacturer Zhejiang Huahai having PSD Value of (D90)= 179 micron upon In-House Testing which is smaller than lower limits. Quantity: 100 Kg  under Approval  Pharma 18/10/2024 Hamza Ahmed  
CMP-0174-2418/10/2024SCMTemporary Revision of Artwork Currently, in Afghanistan Trixafin injection is being marketed with ampoule and WFI . It is proposed that in Afghanistan Trixafin injection is being marketed with ampoule only. under Approval  Pharma 18/10/2024 Hamza Ahmed  
CMP-0175-2422/10/2024ProductionPermanent  Upgradation of Dosing bowl/ rotary container volume and nozzles quantity for the DPI Capsule filling machine SMA -Z25.- Currently Capsule filling machine have two dosing nozzles. - Existing bowl/rotary container accommodates two dossing nozzels.We need to upgrade the bowl size of filling machine to accommodates the four dosing nozzels instead of two nozzels.  under Approval  Pharma 22/10/2024 Hamza Ahmed  
CMP-0176-2424/10/2024QC MicroPermanent MajorAddition of new Air Sampler in Quality Control Cephalosporin Microbiology Laboratory Currently, Merck MAS-100 air sampler is used only for viable count monitoring in cephalosporin area.It is proposed to add Active count 100H for viable count and compressed air monitoring.N/AApproved31/03/2025In ProgressPharma1) URS of air sampler will required. Micro 2) IQ,OQ will be performed. Micro/Validation 3) PQ will be performed. QA-Val 4) SOP will be prepared. Micro 5) Training will be provided on SOP. Micro 6) Calibration will be performed. Micro/ Validation 7) Calibration list will be updated. Micro 1) Nov-24 2) Jan-25 3) Mar-25 4) Mar-25 5) Mar-25 6) Mar-25 7) Mar-25 24/10/202402/11/2024Hamza Ahmed Hamza Ahmed
CMP-0177-2424/10/2024QC MicroPermanent MajorAddition of Cool Incubator in Cephalosporin Quality Control Microbiology laboratoryCurrently cool incubator, Model No. IN-110 Memmert, is used for incubation of tested samples of raw material, finished product and environmental monitoring plates, in Cephalosporin Microbiology Lab.It is propose to add incubator, JS Research Korea Model No. JSBI 250CP, for sample incubation.N/AApproved31/03/2025In ProgressPharma1) URS required of Cool Incubator. Micro 2) IQ, OQ will be performed. Micro/Validation 3) PQ will be performed. Validation 4) SOP will be prepared. Micro 5) Training will be provided on SOP. Micro 6) Calibration will be performed. Validation 7) Calibration list will be updated. Micro 1) Oct-24 2) Jan-25 3) Mar-25 4) Mar-25 5) Mar-25 6) Mar-25 7) Mar-25 24/10/202401/11/2024Hamza Ahmed Hamza Ahmed
CMP-0178-2424/10/2024QC MicroPermanent  Change in width of Cold Formabale Foil for Inosita Plus 50/500mg Tab at Hoonga Blister MachineCurrently Inosita Plus 50/500mg Tab is being blistered with Cold Formable Foil (238mm) at Hoonga Blister Machine.It is proposed to change the width of Cold Formable Foil from 238mm to 244mm for Inosita Plus 50/500mg Tab. under Approval  Pharma 24/10/2024 Hamza Ahmed  
CMP-0179-2425/10/2024QC Permanent  Addition of new HPLC’s in QC (Non-Ceph Lab)Currently, we have the following quantities of HPLC’s in the non-Ceph QC laboratory from Thermo Fisher Scientific. S. No. Instrument Name 01 HPLC Qty Make 02 Thermo It is proposed to add the following quantities of HPLC’s in the non-Ceph QC laboratory from Thermo Fisher Scientific. S. No. Instrument Name 01 HPLC Qty Make 02 Thermo N/Aunder Approval  Pharma 25/10/2024 Hamza Ahmed  
CMP-0180-2425/10/2024QC Permanent  Addition of new HPLC in QC (Ceph Lab)Currently we have following quantities of in the Ceph QC laboratory from Shimadzu. S. No. Instrument Name 01 HPLC Quantity Make 02 Shimadzu It is proposed to add the following quantity of HPLC in QC Ceph Lab. S. No. Instrument Name 01 HPLC Quantity Make 02 Thermo N/Aunder Approval  Pharma 25/10/202425/10/2024Hamza Ahmed Hamza Ahmed
CMP-0181-2425/10/2024QC Permanent  Addition of new Software for HPLC in QC LabCurrently we have one software i.e. Open Lab CDS software for the backup of all HPLC’s. S. No. Instrument Name 01 HPLC Qty Make 07 Shimadzu 05 Agilent 02 Thermo Software Open Lab CDS SoftwareIt is proposed to purchase the another software i.e. Lab Solution CDS Software for the new HPLC’s in QC Laboratory. S. No. Instrument Name 01 HPLC Qty Make 07 Shimadzu 02 Thermo Software Lab Solution CDS SoftwareN/Aunder Approval  Pharma 25/10/2024 Hamza Ahmed  
CMP-0182-2425/10/2024BDPermanent  New Launch product in IRAQThe below mentioned product is not launched in IRAQ. 1) X-Plended EZ 10/10mg TabletIt is proposed to launch this product in IRAQ.N/Aunder Approval  Pharma 25/10/2024 Hamza Ahmed  
CMP-0183-24 29/10/2024PDPermanent MajorNew launch of Carbidopa+ Levodopa CR 25/100mg Tablets in PharmEvo premisesProduct development activities of following generic have been completed in pharmEvo. 1) Carbidopa+ Levodopa CR 25/100mg TabletsIt is proposed to commercialize the following generic in pharmEvo facility. 1) Carbidopa+ Levodopa CR 25/100mg TabletsRA-0045-24Approved31/12/2025In ProgressPharma1) PD trial required with stability report. PD 2) Cleanability report required. PD 3) Technology transfer protocol (for process) is required. PD 4) Technology transfer protocol (for analytical testing) is required. PD 5) Registration letter is required. RA 6) Source approval documents will be submitted to QA. SCM. 7) Raw material codes will be opened. SCM 8) Approved artwork will be developed. BD 9) Packaging material codes will be opened. BD 10) Analytical testing method will prepared and update on LIMS. QC 11) Batch documents (BDR, BMR, BYS, BPR) will prepare. QA 12) Planning of product launch for commercial. BD 13) Process validation will be performed. QA-VAL 14) Product will be charge on stability. QC 1) Done 2) Dec-24 3) Dec-24 4) Dec-24 5) Done 6) Done 7) Done 8) Mar-25 9) Mar-25 10) Mar-25 11) Apr-25 12) Apr-25 13) Dec-25 14) Dec-25 29/10/202405/12/2024Hamza Ahmed Hamza Ahmed
CMP-0184-24 29/10/2024PDPermanent MajorNew product launch of Carbidopa+ Levodopa IR 12.50/50mg tablets, Carbidopa+ Levodopa IR 25/250mg tablets, Carbidopa+ Levodopa IR 25/100mg tabletsProduct development activities of following generics have been completed in pharmEvo. 1) Carbidopa+ Levodopa IR 12.50/50mg tablets 2) Carbidopa+ Levodopa IR 25/250mg tablets 3) Carbidopa+ Levodopa IR 25/100mg tabletsIt is proposed to commercialize the following generic in pharmEvo facility. 1) Carbidopa+ Levodopa IR 12.50/50mg tablets 2) Carbidopa+ Levodopa IR 25/250mg tablets 3) Carbidopa+ Levodopa IR 25/100mg tabletsRA-0046-24 Approved31/12/2025In ProgressPharma1) PD trial required with stability report. PD 2) Cleanability report required. PD 3) Technology transfer protocol (for process) is required. PD 4) Technology transfer protocol (for analytical testing) is required. PD 5) Registration letter is required. RA 6) Source approval documents will be submitted to QA. SCM. 7) Raw material codes will be opened. SCM 8) Approved artwork will be developed. BD 9) Packaging material codes will be opened. BD 10) Analytical testing method will prepared and update on LIMS. QC 11) Batch documents (BDR, BMR, BYS, BPR) will prepare. QA 12) Planning of product launch for commercial. BD 13) Process validation will be performed. QA-VAL 14) Product will be charge on stability. QC Timelines are same for both strengths: 1) Done 2) Dec-24 3) Dec-24 4) Dec-24 5) Done 6) Done 7) Done 8) Mar-25 9) Mar-25 10) Mar-25 11) Apr-25 12) Apr-25 13) Dec-25 14) Dec-25 29/10/202405/12/2024Hamza Ahmed Hamza Ahmed
CMP-0185-2429/10/2024SCMPermanent  Addition of Supplier for Local Materials Currently we are procuring Citric Acid Anhydrous from supplier as per attached sheet. It is proposed to add one more supplier “Brothers Enterprises Pvt Ltd” Address: 106, Anum Estate, Shahrah-e-faisal opp Deuty Free Shop, Karachi. For the procurement of Local materials from the Approved Manufacturer.  under Approval  Pharma 29/10/2024 Hamza Ahmed  
CMP-0186-2429/10/2024SCMPermanent  Addition of Supplier for Local Materials Currently we are procuring Tablettose 80 from supplier as per attached sheet.It is proposed to add one more supplier “Shabbir International” Address: C-12/1, 12th floor Sidco Avenue Centre 264 R A lines, Karachi. For the procurement of Local materials from the Approved Manufacturer.  under Approval  Pharma 29/10/2024 Hamza Ahmed  
CMP-0187-2429/10/2024SCMPermanent  Addition of Supplier for Local Materials Currently we are procuring IPA, Dextrose anhydrous, Titanium dioxide, Aspartame & Citric Acid Anhydrous from supplier as per attached sheet.It is proposed to add one more supplier “3As Trading” Address: office No 03, Plot no 82-C, 9th Commercial Street, DHA, Phase-4, Karachi. For the procurement of Local materials from the Approved Manufacturer.  under Approval  Pharma 29/10/2024 Hamza Ahmed  
CMP-0188-2429/10/2024QAPermanent MinorRevision of Line Clearance SOPCurrently, SOP for the line clearance is available and followed, but all the checks are defined within a single step, without any separation assigned for the different checks.It is proposed to assigned the Separtion in the format of line clearance of manufacturing and packaging to better understand the process. The format is break down into two steps as: 1) 1st step is for the clearance of the previous products in each aspect e.g: cleaning of equipments, Removal of the traces of the previous materials,checking of specified working uniformed etc 2) 2nd step is for the checking of the upcoming product. e.g: each material is checked against the MO, Environment condition verified as per given requirements etc. N/AApproved In ProgressPharma1) SOP of Line Clearance will be revised. QA 2) Batch documents of fast moving products will be revised in first phase. QA 3) Batch documents of slow moving products will be revised in second phase. QA 4) Training will be provided to all concern staff. QA 1) Nov-24 2) Jan-25 3) Apr-25 4) Nov-24 29/10/202407/11/2024Hamza Ahmed Hamza Ahmed
CMP-0189-2431/10/2024PDPermanent  Replacing Sheffcoat White 5Y00625 with Sheffcoat White 5Y01440 Sheffcoat White 5Y00625 is being used various products including PEG in coating process.Sheffcoat White 5Y01440 will be used in replacement of Sheffcoat White 5Y00625 without PEG used additionally. coating suspension to be prepared as 20% dispersion in water. Sheffcoat White 5Y01440  under Approval  Pharma 31/10/202402/11/2024Hamza Ahmed Hamza Ahmed
CMP-0190-2405/11/2024PDPermanent MajorNew Launch product Glycopyrronium +Indacaterol 110/50mcg DPI CapsuleProduct development activities of generic Glycopyrronium +Indacaterol 110/50mcg DPI Capsule has been completed.It is proposed to commercialize the Glycopyrronium +Indacaterol 110/50mcg DPI Capsule in Pharmevo facility.RA-0047-24Approved31/12/2025In ProgressPharma1) PD trial required with stability report. PD 2) Cleanability report required. PD 3) Technology transfer protocol (for process) is required. PD 4) Technology transfer protocol (for analytical testing) is required. PD 5) Registration letter is required. RA 6) Source approval documents will be submitted to QA. SCM. 7) Raw material codes will be opened. SCM 8) Approved artwork will developed. BD 9) Packaging material codes will be opened. BD 10) Analytical testing method will prepared and update on LIMS. QC 11) Batch documents (BDR, BMR, BYS, BPR) will prepare. QA 12) Planning of product launch for commercial. BD 13) Process validation will be perform. QA-VAL 14) Product will be charge on stability. QC 15) Specifications will be developed and update on LIMS. QC 1) Done 2) Jan-25 3) Jan-25 4) Jan-25 5) Jan-25 6) Nov-24 7) Nov-24 8) Jan-25 9) Jan-25 10) Jan-25 11) Feb-25 12) Feb-25 13) Dec-25 14) Dec-25 15) Feb-25 05/11/202405/12/2024Hamza Ahmed Hamza Ahmed
CMP-0191-2405/11/2024PDPermanent  New Launch product Finerenone 10mg and 20mg TabletProduct development activities of generic Finerenone 10mg and 20mg has been completed.It is proposed to commercialize the Finerenone 10mg and 20mg tablet in Pharmevo facility. under Approval  Pharma 05/11/2024 Hamza Ahmed  
CMP-0192-24 05/11/2024SCMPermanent  Additional source Induction of Metformin HClWe are currently procuring Metformin HCl from M/s Smruthi Organics Limited, M/s Aarti Drugs Ltd India, M/s Wanbury Limited.We intend to induct one more source M/s Ningxia Hengkang technology CO., LTD Address: East Road of Hongsheng, Biotech park of Yinchuan, Ningxia, China. under Approval  Pharma 05/11/2024 Hamza Ahmed  
CMP-0193-24 05/11/2024SCMPermanent  Additional source Induction of AgomelatineWe are currently procuring Agomelatine from M/s Changzhou Pharmaceuticals Factory, M/s Mehta API Pvt Ltd & M/s Shankus Pharmaceuticals.We intend to induct one more source M/s Shandong Confucius Pharmaceuticals CO., LTD. Address: The 1st industry road, economical development zone(West District), qufu city, Shandong province, 273100, China  under Approval  Pharma 05/11/2024 Hamza Ahmed  
CMP-0194-24 05/11/2024SCMPermanent  Additional source Induction of Povidone PVP k30We are currently procuring Excipients: Povidone PVP K30 from M/s Ashland& M/s Boai NKY Medical Holdings Ltd.We intend to induct one more source M/s. Yuking technologies CO., Ltd. Address No: 101, Guanyu Road, Xiangyang, Hubei, Chine. under Approval  Pharma 05/11/2024 Hamza Ahmed  
CMP-0195-24 05/11/2024QCPermanent MajorNew launch product Levetiracetam 1000mg tablet Product development activities of generic Levetiracetam 1000mg tablet has been completedIt is proposed to commercialize the Levetiracetam 1000mg tablet in pharmevo facility. Approved31/07/2025In ProgressPharma1) PD trial required with stability report. PD 2) Cleanability and containment report required. PD 3) Technology transfer protocol (for process) is required. PD 4) Technology transfer protocol (for analytical testing) is required. PD 5) Registration letter is required. RA 6) Source approval documents will be submitted to QA. SCM. 7) Raw material codes will be opened. SCM 8) Approved artwork will be developed. BD 9) Packaging material codes will be opened. BD 10) Analytical testing method will prepare and update on LIMS. QC 11) BOM will be created in SAP. QA 12) Batch documents (BDR, BMR, BYS, BPR) will prepare. QA 13) Routing will be created in SAP. Production 14) Planning of product launch for commercial. BD 15) Process validation will be performed. QA-VAL 16) Product will be charge on stability. QC 1) Jan-25 2) Jan-25 3) Jan-25 4) Jan-25 5) Done 6) Done 7) Done 8) Jan-25 9) Jan-25 10) Jul-25 11) Jul-25 12) Jul-25 13) 14) Jul-25 15) Dec-25 16) Dec-25 05/11/202405/12/2024Hamza Ahmed Hamza Ahmed
CMP-0196-2411/11/2024BDPermanent  Additional Batch Size of Setspin 16mg TabletThe existing batch size of the Setspin 16mg Tablet is 60.036Kg.It is proposed to add a batch size of 30.00Kg for Setspin 16mg Tablet. under Approval  Pharma 11/11/2024 Hamza Ahmed  
CMP-0197-2412/11/2024PDPermanent MajorNew Launch Fluticasone propionate/Salmeterol 500/5mcg, 250/50mcg & 100/20mcg DPI capsuleProduct development activities of following generic Fluticasone propionate/Salmeterol 500/5mcg, 250/50mcg & 100/20mcg DPI capsule has been completed. have been completed.It is proposed to commercialize the following generic Fluticasone propionate/Salmeterol 500/5mcg, 250/50mcg & 100/50mcg DPI capsule in pharmEvo facility.N/AApproved In ProgressPharma1) PD trial required with stability report. PD 2) Cleanability and containment report required. PD 3) Technology transfer protocol (for process) is required. PD 4) Technology transfer protocol (for analytical testing) is required. PD 5) Registration letter is required. RA 6) Source approval documents will be submitted to QA. SCM. 7) Raw material codes will be opened. SCM 8) Approved artwork will be developed. BD 9) Packaging material codes will be opened. BD 10) Analytical testing method will prepare and update on LIMS. QC 11) BOM will be created in SAP. QA 12) Batch documents (BDR, BMR, BYS, BPR) will prepare. QA 13) Routing will be created in SAP. Production 14) Planning of product launch for commercial. BD 15) Process validation will be performed. QA-VAL 16) Product will be charge on stability. QC Timelines are same for Fluticasone propionate/Salmeterol 500/5mcg & 250/50mcg 1) Done 2) Nov-24 3) Nov-24 4) Nov-24 5) Done 6) Done 7) Done 8) Done 9) Done 10) Jan-25 11) Dec-24 12) Dec-24 13) Dec-24 14) Jan-25 15) Mar-25 16) Mar-25 Timelines Fluticasone propionate/Salmeterol 100/50mcg 1) Done 2) Nov-24 3) Nov-24 4) Nov-24 5) Done 6) Done 7) Done 8) Done 9) Done 10) Jan-25 11) Jan-25 12) Jan-25 13) Jan-25 14) Jan-25 15) Mar-25 16) Mar-25 12/11/202405/12/2024Hamza Ahmed Hamza Ahmed
CMP-0198-2413/11/2024ProductionPermanent  Installation of automatic bottle counter on liquid filling line.Currently, there is no bottle counter installed on the liquid filling line, resulting in the manual counting of filled bottles for reconciliation on the Batch Manufacturing Record (BMR).It is proposed to install automatic bottle counter on liquid filling line in Production Non-Ceph Liquid Manufacturing area. under Approval  Pharma 13/11/2024 Hamza Ahmed  
CMP-0199-24 14/11/2024PDPermanent  Change in formulation of Fasteso 20mg & 40mg TabletFasteso 20mg & 40mg Tablets being manufacturer as per formulation attached in annexure-1.It is proposed that Fasteso 20mg & 40mg Tablets will be manufacture red as per formulation attached in annexure-1. under Approval  Pharma 18/11/2024 Hamza Ahmed  
CMP-0200-2418/11/2024ProductionPermanent  Transferring of products to Hoonga blister machineThe Products mentioned on the attached list are currently being blistered on BM-350 as per mentioned dimensions (list attached).A/F 216mm & CFF 218mm. 2) Currently Pack size on BM-350 blister machine is 7,s tool. (List attached)The Products mentioned on the attached list are agreed to move to the Hoonga Blister Machine as per mentioned dimensions(list attached). A/F 236mm & CFF 238mm. Dimensions of Unit Carton, Direction Insert & Master Carton will also be changed Accordingly. 2) Pack size will also be change from 7,s to 10,s.(List attached) under Approval  Pharma 18/11/202428/11/2024Hamza Ahmed Hamza Ahmed
CMP-0201-2422/11/2024SCMPermanentMinorAddition of supplier for local materialsCurrently, Mak Kemikal is our approved Supplier as per attached sheet.Now, It is proposed to Purchase Iso Propyl Alcohol (IPA) USP as well from “Mak Kemikal” Approved Manufacturer, LCY Taiwan. MAk Kemikal is Approved supplier for other different materials list attached. N/Aunder Approval  Pharma 22/11/202428/11/2024Zafran MeerHamza Ahmed
CMP-0202-2422/11/2024SCMPermanentMinorAddition of supplier for local materialsCurrently we are procuring Iso Propyl Alcohol (IPA) USP from supplier as per attached sheet.It is proposed to add one more supplier “Alpine Chemical Solutions (Pvt.) Ltd” Address: 29-H, Johar Town, Phase II, Lahore. For the procurement of above mention material from the Approved Manufacturer, LCY Taiwan. N/Aunder Approval  Pharma 22/11/202428/11/2024Zafran MeerHamza Ahmed
CMP-0203-2422/11/2024SCMPermanent Addition of supplier for local materialsCurrently, Mansoor Chem is our approved Supplier as per attached sheet. Now, It is proposed to Purchase Aspartame as well from “Mansoor Chem” Approved Manufacturer, Sino Sweet and Nutra Sweet. Mansoor chem is approved supplier for other different materials list attached.     Pharma 22/11/202428/11/2024Zafran MeerHamza Ahmed
CMP-0204-2428/11/2024QCPermanent MinorTransfer of stability chamber and documents from QC to PD.Following responsibilities related to the stability study program of development batches are currently managed by the QC department: 1. Sample placement and management in the stability chamber. 2. Sample log and inventory of development stability batches. 3. Preparation of a monthly stability plan for development stability batches. 4. Maintenance and calibration of the stability chamber 5. Daily monitoring of the environmental conditions of the stability chamber. As the PD lab has now developed separately, it is proposed to transfer the complete responsibility for stability studies of development batches to the PD section. under Approval  Pharma 28/11/2024 Hamza Ahmed  
CMP-0205-2428/11/2024SCMPermanent MinorAdditional Source induction of LevodopaWe are currently procuring LEVODOPA from M/s Zhejiang Wild Wind Pharmaceutical CO., Ltd. and M/s. Shandong Xinhua Pharmaceutical Co.,Ltd. We intend to induct one more source M/s. Zhejiang Huahai Pharmaceuticals Co Ltd;(Chuannan Site) Add: Chuannan ,Duqiao, Linhai, Zhejiang, 317016, China. under Approval  Pharma 28/11/2024 Hamza Ahmed  
CMP-0206-2402/12/2024SCMPermanent MinorAddition of supplier for local materialsCurrently, Premium chemical is our approved supplier as per attached list.Now, it is proposed to purchased Iso Propyl Alcohol (IPA) USP as well from" Premium Chemicals" approved manufacturer, LCY Taiwan. Premium Chemicals is approved supplier for other different materials list attached. under Approval  Pharma 02/12/202403/12/2024Hamza Ahmed Hamza Ahmed
CMP-0207-2402/12/2024PDPermanent MajorChange in formulation of Ramipace 10mg, 5mg and 2.5mg Tablet• Ramipace 10mg, 5mg, 2.5mg Tablets is being manufactured as per formulation in annexure -1. • Formulation includes Compitrol 880 ATO , MCC-102 , Tablettose 80 lactose monohydrate , Sodium starch glycolate and Colloidal silicon dioxide. • Batch is manufactured using Direct compression. • Product manufacturing cycle is of 45 days. • Manufacturing is done at temperature =30°C. • Packaging of fasteso tablet does not specify the storage temperature. • Ramipace 10mg, 5mg, 2.5mg Tablets will be manufactured as per formulation in annexure -1. • Compitrol 880 ATO , MCC-102 , Tablettose 80 lactose monohydrate , Sodium starch glycolate and Colloidal silicon dioxide are removed and new formulation includes MCC-101 , IPA and water. • Batch manufacturing is done by using wet granulation technique. • Manufacturing cycle of Ramipace to be completed within 7 working days. • Manufacturing to be performed at temperature =25°C • Artwork of ramipace to be revised mentioning the storage temperature i.e. 25°C  under Approval  Pharma 02/12/202403/12/2024Hamza Ahmed Hamza Ahmed
CMP-0208-2404/12/2024PDPermanent MajorNew Launch product of Linagliptin/Metformin HCl XR Tablet 2.5/1000mg & 5mg/1000mg Tablet.Product development activities of following generic have been completed. 1) Linagliptin/Metformin HCl XR Tablet 2.5/1000mg & 5mg/1000mg Tablet.It is proposed to commercialize the following generics in Pharmevo facility. 1) Linagliptin/Metformin HCl XR Tablet 2.5/1000mg & 5mg/1000mg Tablet. under Approval  Pharma 04/12/202406/12/2024Hamza Ahmed Hamza Ahmed
CMP-0209-2405/12/2024BDPermanent  Supply of Emglin(Empagliflozin) Tablets 25mg in Sri Lanka for SPC TenderThe below mentioned product is not being supplied for SPC Tender in Sri LankaIt is proposed to supply this product for SPC tender in Sri Lanka. under Approval  Pharma 05/12/2024 Hamza Ahmed  
CMP-0210-2405/12/2024QAPermanent  Change of Certification Body of ISO-9001, ISO-14001 and ISO-45001Currently PharmEvo has acquired the Integrated Management System (IMS) certifications for ISO-9001:2015 Quality Management System (QMS), ISO-14001:2015 Environment Management System (EMS) and ISO-45001:2018 Occupational Health and Safety Management System (OHSMS) from M/s Lloyds Register Quality Assurance (LRQA) which is UK Based certification body (CB) and accrediated to United Kingdom Accreditation Service (UKAS).PharmEvo will discontinue the services from LRQA for their certification services and switch to another cetification body M/s TUV Austria, Bureau of Inspection and Certification (Pvt.) Limited (TUV BIC) for getting IMS certifications.  under Approval  Pharma 05/12/2024 Hamza Ahmed  
CMP-0211-2409/12/2024PDPermanentMajorIncrease in batch size of Scifix suspension & Change in manufacturing method of Evofix, Scifix & Cezox Dry powder suspension.Currently Scifix Suspension batch size is 100.004Kg (6000packs) The Evofix, Scifix & cezox Suspension, It is proposed to add sieving of API and source using Fitz mill and fill blending in double cone blender.To fullfill market demands. process optimization and containment to minimize personell interaction. Trial documents and results are attached.   In ProgressPharma 10/12/2024 Zafran Meer 
CMP-0212-2411/12/2024SCMPermanent  Consumption of ampule empty printed 5ml & 10ml in Bestrix Injection range.Currently WFI 10ml from ACL is used in Bestrix Inj. 1000mg IV CP & PS and WFI 5ml from surge laboratories is used in Bestrix Inj. 250mg and 500mg IV CP. Manufacturer details of WFI is mentioned on unit carton.It is proposed to used the WFI filled in pharmevo both 5ml & 10ml in bestrix injections range to consume the large inventory as mentioned in below table. Amp. Empty 10mL Printed 822,380 Amp. Empty 5mL Print 557,417 WFI 10ml filled in pharmevo will be consumed in 48 batches of Bestrix Inj. 1000mg IV CP & PS and WFI 5ml filled in pharmevo will be consumed in 32 batches of Bestrix Inj. 250mg and 500mg IV CP & PS. Unit cartons will develop as per pharmevo manufactured WFI details.  under Approval  Pharma 12/12/2024 Hamza Ahmed  
CMP-0213-2411/12/2024SCMPermanent  Change in Manufacturer name of M/s Shangyu Jingxin Pharmaceutical Co., LtdWe have approved MANUFACTURER by the name of M/s Shangyu Jingxin Pharmaceutical Co., Ltd, for APIs listed in Vendor List . Address: No. 31, Weisan Road, Hangzhou Bay Shangyu Economic and Technological Development Area, Shangyu, Zhejiang Province, P.R.China. This is to inform you that M/s Shangyu Jingxin Pharmaceutical Co., Ltd Name has been Changed and New Name of manufacturer will be Shaoxing Jingxin Pharmaceutical Co., Ltd while manufacturing site address will be remain same. New Supplier SAP CODE WILL OPENED. under Approval  Pharma 12/12/2024 Hamza Ahmed  
CMP-0214-24 12/12/2024 SCMPermanent  Consumption of Valsartan Compacted USP.Currently batch size of Avsar Plus Tab. 160/10/12.5mg is 260.00Kg.It is proposed to reduce the batch size of Avsar Plus Tab. 160/10/12.5mg to 132.844Kg to consume the 34.930 kg of Valsartan Compacted USP. under Approval  Pharma 12/12/2024 Hamza Ahmed  
CMP-0215-24 12/12/2024 SCMPermanent  New Vendor Induction for Raw Material EHGCWe are curently procuring EHGC locally from M/s. Gelcaps Pakistan & M/s. Health Capsule Pakistan Pvt. Ltd. FaislabadIt is proposed to Procure EHGC locally also from new vendor M/s. Pharm Nova Pvt. Ltd. which is located at Plot # 54, 193 Deh Khanto Tapo Landhi Bin Qasim Town Ibrahim Hyderi District Malir , Karachi under Approval  Pharma 12/12/2024 Hamza Ahmed  
CMP-0216-24 12/12/2024QAPermanent  Change in Testing procedure for microbial testing.Microbial testing is being performed on every 10th batch for the following dosage form. 1. Tablets (Ceph/ Non-Ceph/ Nutra) 2. Capsule (Ceph/ Non-Ceph) 3. Sachet (Non-Ceph except Actiflor) 4. Dry Suspension (Ceph) 5. SPS JAR 100g/15gMicrobial testing will be performed on each batch for the following dosage form. 1. Tablets (Ceph/ Non-Ceph/ Nutra) 2. Capsule (Ceph/ Non-Ceph) 3. Sachet (Non-Ceph except Actiflor) 4. Dry Suspension (Ceph) 5. SPS JAR 100g/15g under Approval  Pharma 12/12/2024 Hamza Ahmed  
CMP-0217-24 12/12/2024BDPermanent  Launch of Orslim Capsule in Qatar.Currently Orslim 120mg capsule is not launched in Qatar.Orslim 120mg capsule is planned to launch in Qatar. under Approval  Pharma 12/12/2024 Hamza Ahmed  
CMP-0218-24 13/12/2024QCPermanent  Revision of Testing methods Specification of Finish product from In-house to Pharmacopeia(BP & JP)Following products are based on in-house specification as their testing method was not available in USP, BP/EP and JP pharmacopeia. 1. Woncef Injection 1000mg 2. Woncef Injection 2000mg 3. Sefecox Capsule 100mg 4. Sefecox Capsule 200mg The products listed above are now included in the British Pharmacopoeia and Japanese Pharmacopoeia, as methods shown in the table below. As a result, their finished product testing and artwork will be revised to align with the specifications of the British Pharmacopoeia and Japanese Pharmacopoeia. S.no. Product Name Current Specification Pharmacopial Status 1. Woncef Injection 1000mg Pharmevo/Inhouse Specs Japanese Pharmacopeia 2. Woncef Injection 2000mg Pharmevo/Inhouse Specs Japanese Pharmacopeia 3. Sefecox capsule 100mg Pharmevo/Inhouse Specs British Pharmacopeia 4. Sefecox capsule 200mg Pharmevo/Inhouse Specs British Pharmacopeia  under Approval  Pharma 13/12/2024 Hamza Ahmed  
CMP-0219-24 19/12/2024PDPermanent  Change in formulation of Nuval 80mg Tablet and Nuval 160mg TabThe Nuval 160mg & 80mg Tablet is currently being manufactured with PVPK 30, as outlined in the formulation detailed in annexure I.It is proposed to increase the quantity of M.C.Cellulose PH102, Cross povidone, Colloidal Silicon Dioxide, Magnesium Stearate and split the quantity in extragranular and intragranular. Furthermore, Nuval 160mg formulation replaces opadry blue II (85G60990) with lake brilliant blue intragranularly, while the Nuval 80mg formulation replaces opadry Yellow II (85G62338) with iron oxide yellow as specified in the formulation provided in Annexure I. under Approval  Pharma 19/12/2024 Hamza Ahmed  
CMP-0220-24 26/12/2024SCMPermanent      under Approval  Pharma 26/12/2024 Hamza Ahmed  
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2024-2025 QA.