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 ByCreated OnUpdated ByUpdated On
CMP-0001-2601/01/2026RAPermanent Overprinting of QR matrix code, GTIN number and Serial Number on unit cartons of Pharmaceutical products exporting in Uzbekistan and implementation of aggregation process.Currently, products exporting to Uzbekistan only contain batch number, manufacturinng date and expiry date on finished product.1) It is proposed to carry out overprinting of QR matrix codes, GTIN numbers, and serial numbers on the unit cartons of pharmaceutical products intended for export to Uzbekistan as per following information. The QR matrix code will contain specific product and serialization information. This data will provided by our partner in Uzbekistan in the form of an excel sheet. The data in the sheet will be converted in the form of data matrix codes. The information will be unique to each individual unit carton and will be shared by the partner separately for each upcoming order destined for the Uzbekistan market. GTIN number: (Already provided by PharmEvo to partner and will be included in the excel sheet shared by partner) Serial Number: (Will be provided by partner) Individual Sequence number: (Will be provided by partner) Verification code: (Will be provided by partner) While following information will be printed in human readable form in the following format: GTIN: BATCH NO: MFG: EXP: SN: 2) Aggregation process will be implemented for all pharmaceutical products exporting in Uzbekistan.N/AApproved In ProgressPharma1) Serial number, individual sequence number and verification codes required for printing on each unit carton of Uzbekistan order products. (RA) 2) Excel sheet data will be integrated with the PharmaTrax software for code management. (RA) 3) Tertiary packaging (Master carton) label will be generated through pharmatrax software containing all information on unit carton. (RA & Production) 4) Software verification will be performed. QA (Val) 5) Instruction will be incorporate in EPO. (SCM) 6) For every upcoming order for Uzbekistan SCM will inform immediately to RA for the issuance of verification code/ Information in password protected excel sheet. (SCM & RA) 07) SOP to be developed for QR code management for the Uzbekistan. (RA) 08) SOP for the pharmatrax software will be revised to include operation and reconciliation of codes. (Production) 01) Jan-26 02) Jan-26 03) Jan-26 04) Feb-26 05) 06) 07) 08) Hamza Ahmed 01/01/2026Muhammad Haris10/02/2026
CMP-0002-2601/01/2026QC  Due to malfunction observed in the IR system within the QC department, IR based identification testing is temporarily unavailable.Currently, there is a malfunctioning observed in the IR equipment within the QC department, which is preventing the release of materials.All raw materials will be released using alternative identification methods until the IR equipment is operational. Under Approval  Pharma Hamza Ahmed 01/01/2026Hamza Ahmed 07/01/2026
CMP-0003-2607/01/2026QCPermanent Sampling of Nutraceutical APIs will be carried out as per vN +1 rule.Currently, sampling of nutraceutical APIs is performed on 100% of containers for identification.It is proposed that sampling of all nutraceutical APIs will be carried out in accordance with the vN +1 rule.N/AApproved In ProgressPharma1) SOP will be developed. (QC) 2) Training will be provided to concern person. (QC) Hamza Ahmed 07/01/2026Hamza Ahmed 26/01/2026
CMP-0004-2607/01/2026SCMPermanent Alternate source induction for Empty Shell Hard Gelatin Capsule Size 0,1 & 2.We are currently purchasing Empty Hard Gelatin Capsules Size 0,1 & 2 from M/s Health Capsules Pakistan Add: P-25, Phase 1-A, Sahiawala Industrial Estate, FIEDMC, FaisalabadIt is proposed to induct one more source M/s. PharmNova Pvt Ltd. located at Plot # 154 & 93, Deh Kanto Tappo, Landhi Bin Qasim, KarachiN/AApproved In ProgressPharma1) Source approval document will be submitted to QA. (SCM) 2) Procurement of material from new source. (SCM) 3) Vendor list will be updated. (QA) 4) Source name will be added in SAP. (QC) 5) Process validation will be performed. QA(Val) 6) Stability will be performed on validation batches. (QC) 01) Jan-26 02) Jan-26 03) Feb-26 04) 05) 06) Hamza Ahmed 08/01/2026Hamza Ahmed 26/01/2026
CMP-0005-2608/01/2026BDPermanent Revision of Zi-AD Syrup Label (5mg/5ml).The currently approved label dimensions for Zi-AD Syrup are not compatible with the 60ml PET bottle dimensions. Existing label dimensions: 50mmx85mm.Revision of label dimension inline with 60ml PET bottle dimensions. Proposed Label Dimensions: 50mmx85mmN/AApproved In ProgressPharma01) Artwork will be developed. (BD) 02) Item code will be open. (BD) 03) Existing inventory will be write off. (SCM) 04) Old item code will be block for procurement. (SCM) 05) BOM will be revise in SAP. (QA) 01) Done 02) Done 03) Done 04) Done 05) Hamza Ahmed 08/01/2026Hamza Ahmed 26/01/2026
CMP-0006-2613/01/2026BDPermanent  Revision of GTM artworks as per EXGP-S.Currently, all products commercialized in Guatemala are assigned country-specific finished goods (FG) and packaging (PKG) codes. The artworks are also country-specific.Existing artworks will be revised to allign with EXGP-S requirement. The current orders will be processed using the existing Guatemala-specific FG codes with new EXGP-S Artwork. New orders will be subsequently placed using FG codes in accordance with EXGP-SN/A Approved In ProgressPharma01) Notification required from ministry. (RA) 02) Development and approval of artwork. (BD) 03) Item code will be open. (BD) 04) FG code will be open. (SCM) 05) Existing inventory will be write off. (SCM) 06) Old item code will be block for procurement. (SCM) 07) BOM will create in SAP. (QA) 08) BPR will be prepared. (QA) 09) Procurement of packaging material. (SCM) 10) Specification will be updated in SAP. (QC) Hamza Ahmed 13/01/2026Hamza Ahmed 26/01/2026
CMP-0007-2613/01/2026PDPermanent MajorChange in Formulation of Finerdia 10mg tablet & Finerdia 20mg tablet. 1. The product is currently manufactured as per the formulation in Annexure-1 2. Currently Opadry White 03F580033 is being utilized in the formulation.1. The proposed formulation is qualitatively similar to the existing but differs quantitatively as mentioned in annexure-1. 2. Replacing Opadry White 03F580033 with sheffcoat PVA White to improve the physical appearance of tablet.RA-0003-26-PApproved30/04/2026In ProgressPharma01) PD trial is required. (PD) 02) SFG BOM will be revise in SAP. (QA) 03) BDR & BMR will be revise. (QA) 04) Routing will be created in SAP. (Prod) 05) Process Validation will be performed. QA(Val) 06) Stability will be performed on validation batches. (QC) 01) Done 02) Jan-26 03) Jan-26 04) Jan-26 05) April-26 06) April-26 Hamza Ahmed 13/01/2026Hamza Ahmed 26/01/2026
CMP-0008-2613/01/2026EngineeringPermanent  Installation of non-returnable valves at all points of compressed air in the production area.Currently, ball valve are install at compressed air point of use total 31 valves are served in the production areas.It is proposed to installed non return valves at compressed air point of use in order to compliant with GMP requirement.N/AApproved31/03/2026In ProgressPharma01) Installation of non-return valves at all points of compressed air. (Engineering) 02) Inspection of non-return valves will be added in current preventive maintenance program. (Engineering) 03) Chemical testing of product contact point will be perform. QC & QA (Val) 04) Micro testing of product contact point will be perform. QC (Micro) 05) Compressed air layout need to be developed with IDs. (Engineering) 01) Feb-26 02) Feb-26 03) March-26 04) Feb-26 05) Feb-26 Hamza Ahmed 13/01/2026Hamza Ahmed 26/01/2026
CMP-0009-2613/01/2026QAPermanent  Change in Batch Numbering System for Pharma and Nutra products.Currently, batch numbering system for pharma products consist of five alphanumeric characters.(i.e. 6A001) and for nutra batch numbering system consist of six alphanumeric characters.(i.e. N6A001). For Pharma: B.No =6A001 First letter “6” represents the year 2nd letter “A” represents the month of dispensing Last three letters “001”Serial number of batches in a month. For Nutra: B.No =N6A001 First letter “N” represents the nutra 2nd letter “6” represents the year 3rd letter “A”represents the month of dispensing Last three letters “001” serial number of batches in a month.It is proposed to change the batch numbering system for pharma products to six Alphanumeric characters.(i.e. 26A001) and for nutra batch numbering system to seven alphanumeric characters.(i.e. N26A001). For Pharma: B.No =26A001 First two letter “26” represents the year 3rd letter “A” represents the month of dispensing Last three letters “001”Serial number of batches in a month. For Nutra: B.No =N26A001 First letter “N” represents the nutra 2nd and 3rd letter “26” represents the year 4th letter represents the month of dispensing Last three letters 001=Serial number of batches in a month.N/AApproved01/02/2026In ProgressPharma Hamza Ahmed 13/01/2026Hamza Ahmed 26/01/2026
CMP-0010-2615/01/2026BDPermanent Revision in PS Unit Carton Dimensions for Emglin 25mg Tablets- Central America.Current;y, the dimensions of the U/C are not adequate to accommodate the Direction Insert (DI). Existing U/C Dimension: 85mmx60mmx15mm.The U/C dimensions of Emglin 25mg Tablet (PS) will be revised to align with the size requirements of the Direction Insert (DI). Proposed U/C Dimension: 95mmx70mmx20mm.N/AApproved In ProgressPharma01) Development and approval of artwork. (BD) 02) Item code will be open. (BD) 03) Existing inventory will be write off. (SCM) 04) Old item code will be block for procurement. (SCM) 05) BOM will be create in SAP. (QA) 06) BPR will be prepared. (QA) 07) Procurement of packaging material. (SCM) 08) Specification will be updated in SAP. (QC) 01) Done 02) Done 03) Feb-26 04) Feb-26 05) Feb-26 06) Feb-26 07) Feb-26 08) Feb-26 Hamza Ahmed 15/01/2026Muhammad Haris10/02/2026
CMP-0011-26 16/01/2026ProductionPermanent  Transfer of export group A (EXGP-A) products to Hoonga blister machine.The products mentioned on the attached list are currently being blistered on BM-350 blister machine (List attached).The products mentioned on the attached list are agreed to move to the Hoonga Blister Machine. (list attached) Under Approval In ProgressPharma Hamza Ahmed 16/01/2026Muhammad Haris06/02/2026
CMP-0012-26 16/01/2026QCTemporary Temporary use of QC ceph lab UV spectrophotometer for QC general pharma testing.The UV spectrophotometer (UV-01) installed in the QC General Pharma area is out of order. Therefore, batches requiring UV analysis are currently pending at QC testing.It is proposed that samples to be prepared in the QC General Pharma area and then sent to the QC Ceph Lab for performing the UV analysis. The samples will be discarded in the Ceph lab after analysis to avoid cross-contamination. Documents (UV report) will be shared via email. All the raw data and other documents will be maintained in General Pharma QC Lab.N/AApproved In ProgressPharma01) Vendor inspection report required. (QC) 02) Evidence of all activities perform in Ceph area will be perform. (QC) 03) Performance qualification will be perform. (QC) 01) March-26 02) March-26 03) March-26 Hamza Ahmed 16/01/2026Muhammad Haris10/02/2026
CMP-0013-2616/01/2026SCMPermanent  Institution order of MCC KPK.Order of MCC KPK is received from institution market.We have reviewed order of following products from MCC KPK. 01) BOM code: BOM code required. Product: Cap Zoltar 40mg. Material Status: AF need to be develope. Order Qty: 145,000. Institute: MCC KPK Supplies 2025-26. 02) BOM code: BOM code required. Product: Tab Tansin 50mg. Material Status: AF need to be develope. Order Qty: 90,000. Institute: MCC KPK Supplies 2025-26. 03) BOM code: BOM code required. Product: Tab Zilfom 400mg. Material Status: AF need to be develope. Order Qty: 52,000. Institute: MCC KPK Supplies 2025-26. 04) BOM code: BOM code required. Product: Tab Evopride 2mg. Material Status: AF need to be develope. Order Qty: 10,500. Institute: MCC KPK Supplies 2025-26. 05) BOM code: BOM code required. Product: Tab Aireez 10mg. Material Status: AF need to be develope. Order Qty: 10,000. Institute: MCC KPK Supplies 2025-26. For Aluminium Foil: Base color in green with stamp of "GOVERNMENT OF KHYBER PAKHTUNKHWA MCC SUPPLY- NOT FOR SALE". Commercial Packs with stamp of "GOVERNMENT OF KHYBER PAKHTUNKHWA MCC SUPPLY- NOT FOR SALE". N/AApproved In ProgressPharma01) Development and approval of artwork. (BD) 02) Item code will be open. (BD) 03) FG code will be open. (SCM) 04) BOM will be created in SAP. (QA) 05) BPR will be prepared. (QA) 06) Specification will be updated in SAP. (QC) 01) Done 02) Done 03) Done 04) Feb-26 05) March-26 06) April-26 Hamza Ahmed 16/01/2026Muhammad Haris10/02/2026
CMP-0014-2616/01/2026QAPermanent  Change of PW loop temperature from 80ºC to ambient temperature (25-30ºC).Currently Purified water is continuously circulated in loop at 80ºC (±5ºC) and treated water at ambient temperature.It is proposed to reduce temperature of purified water loop to ambient temperature (25-30ºC). However, due to this purpose change sanitization frequency need to be defined and qualification of purified water system loop will be performed.  Approved In ProgressPharma Hamza Ahmed 16/01/2026Hamza Ahmed 26/01/2026
CMP-0015-2621/01/2026SCMTemporary Over printing of suffix with batch number for the identification of different shelf life in same batch.The Products(s) and Batch(es) has already been packed & invociesd as per procedure for export in FWA region.We need to over print batch. no with mentioning the suffix for identification of different shelf life in sam batch (i.e 24 months(s) and 36 months(s)). Details of products with complete details is attached. Under Approval  Pharma Hamza Ahmed 21/01/2026  
CMP-0016-2622/01/2026QAPermanent  To implement microbiological assay testing on every batch of Cephalosporin suspension products.Previously micro testing was performed on every tenth batch of Cephalosporin suspension products.It is proposed to conduct micro testing on every batch of Cephalosporin suspension products. Under Approval  Pharma Hamza Ahmed 22/01/2026  
CMP-0017-2622/01/2026QCPermanent  Procurement & Induction of a new semi micro balance Mettler Toledo Model: MA55.Semi-Micro balance XSR105DU (Asset No. 1500000865) has experienced a critical hardware malfunction. The balance has been sent to the Vendor (Rauf Electronics) for diagnosis. Diagnosis indicates the failure of HMI device.Semi-Micro balance XSR105DU (Asset No. 1500000865) will be traded off to Vendor (Rauf Electronics) for a new semi micro balance (Model: MA55). New equipment ID and asset number will be allotted as per procedure.N/A Approved OpenedPharma1) CAPEX of new semi micro balance to be generated. (QC) 02) Asset trade form to be generated. (QC) 03) IQ and OQ will be perform. (QC) 04) SOP will be prepared. (QC) 05) PQ will be perform. QA(Val) 06) Instrument list will be updated. (QC) 07) Calibration list will be updated. QA(Val) 01) Feb-26 02) Feb-26 03) April-26 04) April-26 05) April-26 06) May-26 07) May-26 Hamza Ahmed 22/01/2026Muhammad Haris06/02/2026
CMP-0018-2623/01/2026ProductionPermanent  Tranferring of products to Hoonga Blister Machine Local CPThe products mentioned on the attached list are currently being blistered on 2DT blister machine as per mentioned dimensions (list attached). A/F 170mm & CFF 175mm. (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 288mm & CFF 290mm.N/AUnder Approval  Pharma Hamza Ahmed 23/01/2026Muhammad Haris06/02/2026
CMP-0019-2623/01/2026SCMPermanent Change in Manufacturer nameWe have approved manufacturer by the name of M/s. Venkata Narayana Active Ingredients Private Limited. Address: Sy. No.69, Chandrapadiya Village, Vinjamur Mandal, S.P.S.R. Nellore District-524 228. Andhra Pradesh.It is proposed that manufacturer name has been changed to M/s. Chieron Active Ingredients Pvt. Ltd. Address: While the manufacturer site/material will remain same.N/AUnder Approval  Pharma Hamza Ahmed 23/01/2026Hamza Ahmed 26/01/2026
CMP-0020-2630/01/2026SCMPermanent  Change of Name and manufacturing site for API Manufacturer M/S PRUDENCE PHARMA CHEMWe are currently procuring APIs Amlodipine Besylate, Febuxostat, Glimepiride from M/S PRUDENCE PHARMA CHEM located at Plot no. 7407, GIDC Estate, Ankleshwar- 393002, Bharuch, Gujarat, India.Now manufacturer has changed their name to M/S Pridence Lifecare Pvt Ltd and site to a new WHO GMP certified facility which is located at plot no. 6104/6 GIDC industrial estate, Ankleshwar- 393002 Gujrat, India and will start supplying from new facility with new name from June, 2026 onwards. New site will be inducted in Pharmevo as per new details given. Under Approval  Pharma01) Variation will be submitted in loacal and export countries. (RA) 02) Source approval documents from the new site will be submitted to QA. (SCM) 03) Vendor list will be updated. (QA) 04) New manufacturer name and site will be added in SAP and previous name and site will be deleted. (QA) 05) Procurement of raw material form new site of the manufacturer. (SCM) 06) Process validation will be perform on three consecutive batches. QA(Val) 07) Stability will be perform on validation batches. (QC) Muhammad Haris30/01/2026Muhammad Haris10/02/2026
CMP-0021-2630/01/2026RAPermanent  Change in batch size of SPS 100g Jar.Currently batch size of SPS 100g SFG Jar is 35Kg. It is ready to fill product.It is proposed to change this to flexible batch size to meet market demand. Under Approval  Pharma01) BOM will be revise in SAP. (QA) 02) BDR will be revise. (QA) Muhammad Haris30/01/2026Muhammad Haris10/02/2026
CMP-0022-2602/02/2026ProductionPermanent  Change of Pack size for local manufacturing of Xcept 15mg and 20mg tablet.At present, the below mentioned products are blister on the BM-350 using 10's blister tooling. During operation, three blister pockets are intentionally left empty (Pic attached). The final pack configuration is 14's (2 x 7 tablets). 1. Xcept 15mg tab. 2. Xcept 20mg tab.It is now proposed to utilize all blister pockets during blister operations on the BM-350. The existing blister tooling will be used without leaving any empty pocket. New pack size will be decided in change impact assessment. Under Approval  Pharma Muhammad Haris02/02/2026Muhammad Haris06/02/2026
CMP-0023-2602/02/2026WarehousePermanent  To change the format of GI, LC and MO in BDR and BPR.In BDR, 1. In LC differential pressure of dispensing areas and laminar air pressure not mentioned. 2. In LC Expiry date of API is mentioned. 3. In MO, QC lot, Net qty issued, tare weight, gross weight , dispensed by, checked by, potency and adjustment are mention manually at the time of dispensing. In SAP generated GI. In GI columns with heading (To) (Balance) and (Status) are mentioned.In BDR, 1. In LC differential pressure of dispensing areas and laminar air pressure will be added. 2. In LC Expiry date of API will be removed , as it is mentioned in GI. 3. In MO, QC lot, net qty issued, tare weight, gross weight, dispensed by, checked by, potency and adjustment will be removed because it is already part of GI. In SAP generated GI In GI columns with heading (To) (Balance) and (status) will be removed and further two columns with heading (dispensed by) (checked by) will be added GI.  Under Approval  Pharma Muhammad Haris02/02/2026  
CMP-0024-2602/02/2026RAPermanent  Spelling correction in the artwork of Aireez 4mg Sachet- VietnamA few spelling mistakes were identified in the DI of Aireez Sachet 4mg (Vietnamese Language).The partner has requested correction of the spelling mistakes in the DI. Under Approval  Pharma Muhammad Haris02/02/2026Muhammad Haris06/02/2026
CMP-0025-2602/02/2026BDPermanent  Launch of New Product in Ghana.The product mentioned below are not launched in Ghana yet. Product: Galvecta Plus 50/500mg. Generic: Vildagliptin+ Metformin. Pack Size: 56's. Shelf Life: 24months. Registration Timeline: Registered. Product: Galvecta Plus 50/1000mg. Generic: Vildagliptin+ Metformin. Pack Size: 56's. Shelf Life: 24months. Registration Timeline: Registered.These products are planned for launch in Ghana. Under Approval  Pharma01) Registration letter required. (RA) 02) Product launch in Ghana. (BD) 03) Development and approval of artwork. (BD) 04) New item code will be open. (BD) 05) FG code will be open. (SCM) 06) BOM will be create in SAP. (QA) 07) BPR will be prepared. (QA) 08) Procurement of packaging material. (SCM) 09) Specification will be developed in SAP. (QC) Muhammad Haris02/02/2026Muhammad Haris10/02/2026
CMP-0026-2603/02/2026SCMPermanent  Alternate Vendor Qualification for Omeprazole Pellets from Vision Pharmaceutical (Pvt) Ltd. Site Address: Plot No: 22-23, Industrial Triangle Kahuta Road, Islamabad, PakistanOmeprazole pellets are currently procured from M/S Cohance Life Sciences and comply with the USP dissolution Test I. However, due to relocation and ongoing development of the supplier’s manufacturing facility, procurement from Cohance Life Sciences is currently not feasible. Site Address: Plot No. A-19C, A-23A & A-23B      Pharma Muhammad Haris03/02/2026  
CMP-0027-2604/02/2026BDPermanent  Currently, products launched in FWA are categorized based on specific countries.Products will be categorized into two groups based on shelf life instead of region/ countries: 1. FWA-A: 24 months 2. FWA-B: 36 months Finished products codes will be created according to these groups. Packaging material codes (A/F, U/C, D/I) will remain unchanged.  Under Approval  Pharma Muhammad Haris04/02/2026  
CMP-0028-2609/02/2026Warehouse  Change in the dispensing process of EHGC shell.Currently, we dispensed EHGC shell in Kg but in MO EHGC shell mention in NOS and we also receive EHGC in NOs. As we know that EHGC are moisture sensitive, multiple time cartons are open for dispensing of EHGC shell and there is chance of shell damages due to edges of scoop. We will dispense the MO quantity of EHGC shells in NOs as mentioned by vendor on the container. Only loose quantity will be dispensed in Kg. Under Approval  Pharma Muhammad Haris09/02/2026Muhammad Haris10/02/2026
CMP-0029-26 12/02/2026QAPermanent  Change in finished product specification of Perabactum Injection range (1g IV/IM, 2g IV/IM)Currently, Perabactum Injection Range specification is aligned as per Japanese Pharmacopoeia (JP).It is proposed to revise finished product specifications of Perabactum Injection range from Japanese Pharmacopoeia (JP) specification to the Innovator's specifications. Under Approval  Pharma Hamza Ahmed 12/02/2026Muhammad Haris13/02/2026
CMP-0030-2612/02/2026QCPermanent  Transfer of Stability Chamber responsibility from Quality Control to Product Development.As per the current procedure, the Quality Control (QC) department is responsible for the maintenance and calibration of stability chamber 01, 02, 08, 10, 12 and 16, which are used by the Product Development (PD) department.It is proposed that the responsibility for maintenance and calibration of stability chambers 01, 02, 08, 10, 12 and 16 is transferred to the Product Development (PD) department. Under Approval  Pharma Muhammad Haris12/02/2026Muhammad Haris12/02/2026
CMP-0031-26 13/02/2026Warehouse  eWMS      Pharma Hamza Ahmed 13/02/2026  
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2024-2025 QA.