|
| CMP-0001-25 | 03/01/2025 | Engineering | Permanent | Minor | Installation of blister inspection systems in non-ceph blisters machines BM-350(A,B,C,D &E) and 2DT blister machine | Currently, none of the blister machines in the non-ceph blister area are equipped with a blister inspection system. | It is proposed to install the blister inspection system in non-ceph blister machines. i.e BM-350A, BM-350B, BM-350C, BM-350D, BM-350E and 2DT blister.The inspection system will identify the empty pockets in blister,broken tablets,color and size variation.Inspection system will be implemented in two phases as mentioned below;
Phase 01 Phase 02
Blister Machine BM-350 (A) Blister Machine BM-350 (B)
Blister Machine BM-350 (C) Phase 02
Blister Machine BM-350 (D)
Blister Machine BM-350 (E) 2DT Blister Machine
| N/A | Approved | 30/06/2025 | In Progress | Pharma | 1) Installation of blister inspection system. engineering
2) Qualification of blister machines with inspection system will be performed.
QA
3) SOP of blister machines will be revised. Production
4) Training will be provided.
Production
5) SOP of Preventive maintenance will be revised. engineering
| 1) Blister inspection system has been installed on blister machine A, B, C, D & E.
2) Qualification has been performed on blister machine A, B, C, D & E.
| 1) Phase 01: April-25(Extension till Jun-25), phase 02 : June-25
2) Phase 01: April-25(Extension till Jun-25), phase 02 : June-25(Extension till Jun-25)
3) June-25(Extension till July-25)
4) June-25(Extension till July-25)
5) June-25(Extension till July-25)
| 03/01/2025 | 04/07/2025 | Hamza Ahmed | Hamza Ahmed |
|
| CMP-0002-25 | 14/01/2025 | Production | Permanent | Minor | To permit/allow filling/bliserting and packing of Sachet, Syrup, Tablet and Capsule on the basis of physical testing conducted by QA. | Currently, the filling/blistering and packing of sachets, syrups, capsules, and tablets begin only after the release(completion of both chemical and physical testing) of the product in Nutraceutical and Non-Ceph Production. | It is proposed to permit/allow the filling/blistering and packing of sachets, syrups, tablets, and capsules based on physical testing conducted by QA.
Bi-layer products and API-coated products are excluded from this provision.
| RA-0002-25 | Approved | 30/06/2025 | In Progress | Pharma | 1) SOP of “Release of semi - finished products for filling /Blistering and packing” QAG/2/088 will be developed. QA
2) Training will be provided to concern staff. QA
3) As per SOP QAG/2/088 “, QA will release the product as per the released report for filling/blistering and packaging of tablet having Document no QAG/5/314. After satisfactory results QA will allow the production to proceed for next step i.e. filling of tablet, blistering and packing. QA
4) Final Batch will be released after satisfactory QC results. QA
5) Procedure will be in cooperate in SAP for the intermediate released. QA
| 1) SOP has been revised. (Done)
2) Training has been provided. (Done)
3) Done
4) Done
| 1) Jan-25
2) Jan-25
3) Feb-25
4) Feb-25
5) June-25
| 14/01/2025 | 15/04/2025 | Hamza Ahmed | Hamza Ahmed |
|
| CMP-0003-25 | 14/01/2025 | RA | Permanent | Minor | Change in the weight variation of the Erli 10mg as per the request from MOH Uzbekistan. | Current weight variation of Erli 10mg is on 7.5% of target weight of tablet as per United State Pharmacopoeia (USP). | Weight variation of Erli 10mg will be 5% of target weight of tablet as per Uzbek Pharmacopoeia (aligned with the European Pharmacopoeia). | N/A | Approved | 28/02/2025 | Closed | Pharma | 1) Testing method and LIMS specification will be revised.
| 1) Testing method and LIMS specification has been revised.
| 1) Feb-25
| 14/01/2025 | 21/04/2025 | Hamza Ahmed | Hamza Ahmed |
|
| CMP-0004-25 | 14/01/2025 | Production | Temporary | Minor | QC Release Required for Primary Packaging | Currently, we are getting QC release labels for filling/blistering and Packaging after the completion of chemical & Physical Testing. | It is proposed to permit/allow the filling/blistering and packing of the products mentioned below before QC released:
1)Inosita Plus 50/500mg Tab [Batch # (4N197,5A016,5A018,5A019,5A020,5A028)]
2)Xplended 10mg Tab [Batch # (5A098,5A099,5A100)]
3)Xplended 5mg Tab [Batch # (5A094)]
Batch will be released after satisfactory QC results.
| N/A | Approved | 31/01/2025 | Closed | Pharma | 1) Final batch will be released after satisfactory QC results.
| 1) Done
| 1) Mar-25
| 14/01/2025 | 22/04/2025 | Hamza Ahmed | Hamza Ahmed |
|
| CMP-0005-25 | 15/01/2025 | IT | Permanent | Minor | Upgradation in SAP HANA | Currently SAP HANA version 1709 is being used in the company. | It is proposed to upgrade the version to 2023 of SAP HANA to embrace updated software with new features. | N/A | Approved | 31/07/2025 | Closed | Pharma | 1) Upgradation of SAP Software in a controlled test environment
Vendor
2) Provision of test system to users for checking MIS
3) Testing of system (tocdes) by the end users.
All power users/backup users
4) Test results by end users to be compiled and verified MIS
5) Software validation will be performed. QA-VAL
| 1) Done
2) Done
3) Done
4) Done
5) Done
| 1) Mar-25
2) Apr-May-25
3) June-25
4) July-25
5) July-25-Aug-25
| 16/01/2025 | 04/07/2025 | Hamza Ahmed | Hamza Ahmed |
|
| CMP-0006-25 | 16/01/2025 | PD | Permanent | Major | Increased in batch size and change in manufacturing method of Evorox suspension | Currently Evorox suspension batch size is 100.00Kg.
The Evorox suspension is currently being manufactured as Wet granulation method using Manesty mixer and drum blender. | It is proposed to scaleup the batch size to 200.00Kg.
In manufacturing method of Evorox suspension, it is proposed to add sieving of sucrose using Fitz fill and mixing with API then final blending will be performed in double cone blender. | RA-0003-25 | Approved | 30/04/2025 | In Progress | Pharma | 1) PD trial is requried PD
2) SFG and FG BOM, BDR, BMR and will be revised. QA
3) Process validation will be performed. QA
4) Stability will be performed on three commercial batches. QC
5) SAP routing will be created in SAP. Production
6) Variation will be submitted.
| 1) Done
2) SFG, FG BOM, BDR and BMR has been revised.
3) PV has been performed.
4) Product has been charged on stability.
5) Done
| 1) Done
2) Jan-25
3) Apr-25
4) Apr-25
5) Jan-25
6) Sep-25
| 16/01/2025 | 21/04/2025 | Hamza Ahmed | Hamza Ahmed |
|
| CMP-0007-25 | 16/01/2025 | QC | Permanent | Minor | Assay testing of tablets and capsules at blister stage for every 10th batch for Ceph and Non Ceph area | Currently, no testing is conducted at the blistering stage of tablets and capsules in both Cephalosporin and Non-Cephalosporin products. | It is proposed to add the following in SOP of testing of finished products.
1) Assay testing will be performed at blistering stage for every 10th batch of tablet and capsule.
2) Products that are slow moving and who's 10 batches are not produced in a year,
any one batch produced in the same year will be tested from the retention samples to fulfill
the requirements.
3) The product will be released based on the bulk stage testing as per current procedure while
the testing of every 10th batch after blistering will be done for monitoring of impact of
primary packaging process of tablet and capsule.
4) A review of impact of blistering process will be conducted by assessing the results of bulk
and blistered batches at the end of each year.
| N/A | Approved | 28/02/2025 | Closed | Pharma | 01) SOP of “sampling of intermediate and finished products” QAG/2/002
will be revised and training will be provided to all concern staff. QA
02) SOP for raw material, semi-finished and finished product analysis” QCG/2/023 will be revised to incoperate the procedure of assay testing at blistering stage and training will be provided to all concern staff. QC
| Both actions have been completed.
1) SOP has been developed, and training has been provided to concern staff.
2) SOP has been developed, and training has been provided to concern staff.
| 1) Feb-25
2) Feb-25
| 16/01/2025 | 06/05/2025 | Hamza Ahmed | Hamza Ahmed |
|
| CMP-0008-25 | 16/01/2025 | PD | Permanent | MAJOR | New launch product Fluticasone Furoate/ Umeclidinium/ Vilanterol 200/62.5/25mcg & 100/62.5/25mcg DPI capsule. | Product development activities of generic Fluticasone Furoate/ Umeclidinium/ Vilanterol 200/62.5/25mcg & 100/62.5/25mcg DPI capsule has been completed. | It is proposed to commercialize Fluticasone Furoate/ Umeclidinium/ Vilanterol 200/62.5/25mcg & 100/62.5/25mcg DPI capsule in pharmevo facility. | RA-0004-25 | Approved | 28/02/2025 | Closed | Pharma | 1) PD trial documents are required. PD
2) Long term and accelerated stability data required of six months. PD
3) Cleanability and containment report is required. PD
4) Technology transfer protocol (for process) is required. PD
5) Technology transfer protocol (for analytical testing) is required. PD
6) Registration letter is required. RA
7) Source approval documents will be submitted to QA for all three API’s. SCM
8) Artwork will be developed and approved. BD
9) Packaging material codes will be opened. BD
10) SFG and FG codes will be opened. QA
11) Analytical testing method will prepared and update on LIMS. QC
12) BOM will be created in SAP for both SFG and FG stages. QA
13) Batch documents (BDR, BMR, BYS, BPR) will prepare. QA
14) Planning of product launch for commercial. BD
15) Process validation will be perform. QA
16) Product will be charge on stability. QC
17) Routing will be created in SAP. Production
18) Packaging material specification will be update/Create. QC
| Closed without implementation.
| Timelines are same for both strength
1) Done
2) Apr-25
3) Apr-25
4) Apr-25
5) Apr-25
6) July-25
7) May-25
8) July-25
9) July-25
10) July-25
11) Aug-25
12) Sep-25
13) Sep-25
14) Aug-Sep-25
15) Mar-26
16) Sep-26
17) Aug-25
18) Sep-25
| 16/01/2025 | 04/07/2025 | Hamza Ahmed | Hamza Ahmed |
|
| CMP-0009-25 | 16/01/2025 | PD | Permanent | Major | New launch product Indacaterol/ Glycopyrronium/ Mometasone Furoate 150/50160mcg DPI capsule. | Product development activities of generic Indacaterol/ Glycopyrronium/ Mometasone Furoate 150/50/160mcg DPI capsule has been completed. | It is proposed to commercialize Indacaterol/ Glycopyrronium/ Mometasone Furoate 150/50/160mcg DPI capsule in pharmevo facility. | RA-0005-25 | Approved | 30/09/2026 | In Progress | Pharma | 1) PD trial documents are required. PD
2) Long term and accelerated stability data required of six months. PD
3) Cleanability and containment report is required. PD
4) Technology transfer protocol (for process) is required. PD
5) Technology transfer protocol (for analytical testing) is required. PD
6) Registration letter is required. RA
7) Source approval documents will be submitted to QA for all three API’s. SCM
8) Artwork will be developed and approved. BD
9) Packaging material codes will be opened. BD
10) SFG and FG codes will be opened. QA
11) Analytical testing method will prepared and update on LIMS. QC
12) BOM will be created in SAP for both SFG and FG stages. QA
13) Batch documents (BDR, BMR, BYS, BPR) will prepare. QA
14) Planning of product launch for commercial. BD
15) Process validation will be perform. QA
16) Product will be charge on stability. QC
17) Routing will be created in SAP. Production
18) Packaging material specification will be update/Create. QC
| 1) PD trial has been performed and three months accelerated, and long terms stability is available. (Done)
2) Done
7) Indacaterol and Glycopyronomium source has been approved.
| 1) Done
2) Apr-25
3) Apr-25(Extension till Aug-25)
4) Apr-25 (Extension till Sep-25)
5) Apr-25 (Extension till Sep-25)
6) July-25
7) May-25((Extension till Aug-25)
8) July-25
9) July-25
10) July-25
11) Aug-25
12) Sep-25
13) Sep-25
14) Aug-Sep-25
15) Apr-26
16) Oct-26
17) Aug-25
18) Sep-25
| 16/01/2025 | 04/07/2025 | Hamza Ahmed | Hamza Ahmed |
|
| CMP-0010-25 | 16/01/2025 | PD | Permanent | Major | New launch product Umeclidinium/ Vilanterol 62.5/25 mcg DPI capsule. | Product development activities of generic Umeclidinium/ Vilanterol 62.5/25mcg DPI capsule has been completed. | It is proposed to commercialize Umeclidinium/ Vilanterol 62.5/25mcg DPI capsule in pharmevo facility. | N/A | un approved | | Closed | Pharma |
| During impact assessment it was decided that change control is closed without implementation.
|
| 16/01/2025 | 24/01/2025 | Hamza Ahmed | Hamza Ahmed |
|
| CMP-0011-25 | 20/01/2025 | SCM | Permanent | Major | Additional source induction of sofosbuvir | We are currently procuring sofosbuvir from M/s Ruyuan HEC Pharmaceuticals and Nantong Chanyoo | We intend to induct one more source M/s Fuxin long Rui Pharmaceutical Co., Ltd. Address: Fluoride Industrial Park, Fumeng County (Yi Ma Tu), Fuxin City, Liaoning Province 123000, China. | N/A | Approved | 30/04/2026 | In Progress | Pharma | 1) Source approval documents will be submitted to QA. SCM
2) Procurement of material form new source. SCM
3) Vendor list will be update. QA
4) Source name will be added in LIMS. QC
5) Process validation will be performed. QA
6) Stability will be performed on validation batches. QC
| 1) Source approval documents have been submitted to QA. (Done)
2) Material has been procured from new vendor.
3) Vendor list has been updated.
4) Done
| 1) Feb-25
2) April-25
3) April-25
4) April-25
5) April-26
6) April-26
| 20/01/2025 | 30/06/2025 | Hamza Ahmed | Hamza Ahmed |
|
| CMP-0012-25 | 20/01/2025 | SCM | Permanent | Major | Additional source induction of Velpatasvir Copovidone | We are currently procuring sofosbuvir from M/s Ruyuan HEC Pharmaceuticals | We intend to induct one more source M/s Fuxin long Rui Pharmaceutical Co., Ltd. Address: Fluoride Industrial Park, Fumeng County (Yi Ma Tu), Fuxin City, Liaoning Province 123000, China. | N/A | Approved | 30/04/2026 | In Progress | Pharma | 1) Source approval documents will be submitted to QA. SCM 2) Procurement of material form new source. SCM 3) Vendor list will be update. QA 4) Source name will be added in LIMS. QC 5) Process validation will be performed. QA 6) Stability will be performed on validation batches. QC
| 1) Source approval documents have been submitted to QA. (Done)
2) Material has been procured from new vendor.
3) Vendor list has been updated.
4) Done
| 1) Feb-25
2) April-25
3) April-25
4) April-25
5) April-26
6) April-26
| 20/01/2025 | 30/06/2025 | Hamza Ahmed | Hamza Ahmed |
|
| CMP-0013-25 | 22/01/2025 | PD | Permanent | Major | Change in formulation of Lowplat 75 mg Tablet. | The Lowplat 75 mg Tablet is currently being manufactured with Sheffcoat PVA white 5Y01440 and without a seal coat, as outlined in the formulation detailed in Annexure I. | It is proposed to replace Sheffcoat PVA white 5Y01440 with opadry AMB II and implement seal coating in the formulation provided in Annexure I. | RA-0006-25 | Approved | 31/12/2025 | In Progress | Pharma | 1) PD trial is required. PD
2) Accelerated and long-term stability required (six months) PD
3) Variation will be applied in export market. RA
4) Ethyl Cellulose (Ethocel 1D36399) will be procured. SCM
5) SFG BOM will be revised. QA
6) BDR and BMR will be revised. QA
7) Process validation will be performed. QA-VAL
8) Testing method will be revised. QC
9) LIMS specs will be revised. QC
10) Stability will be performed. QC
11) Routing will be created in SAP. production
| 1) PD trial has been performed and three months accelerated, and long terms stability is available. (Done)
2) Done
3) Done
4) Ethyl Cellulose has been procured.
| 1) Done
2) May-25
3) Jan-26
4) May-25
5) May-25(Extension till Aug-25)
6) May-25(Extension till Aug-25)
7) Dec-25
8) May-25
9) May-25((Extension till Aug-25)
10) Oct-25 to Dec-25
11) May-25(Extension till Aug-25)
| 22/01/2025 | 04/07/2025 | Hamza Ahmed | Hamza Ahmed |
|
| CMP-0014-25 | 22/01/2025 | PD | Permanent | SCM | Change of CFF from 238mm to 244mm. | Currently Cold Formable Foil 238mm Self-Printed is being used no. of products (list attached | It is proposed to replace Cold Formable Foil 238mm Self-Printed with Cold Formable Foil 244mm Self-Printed in no of products list attached. | N/A | Approved | 28/02/2025 | Closed | Pharma | 1) BOM will be revised. QA
2) POI will be revised. QA
| All actions have been completed.
1) All BOM has been revised.
2) POI has been revised.
| 1) Feb-25
2) Feb-25
| 23/01/2025 | 19/04/2025 | Hamza Ahmed | Hamza Ahmed |
|
| CMP-0015-25 | 22/01/2025 | PD | Permanent | Minor | Addition of new instrument in new PD Laboratory. | Currently we have following quantity of HPLC, Dissolution Tester and other Instrments.
S. No. Instrument Name Quantity
01 HPLC 08
02 Dissolution Tester 04
03 UV-Spectrophotometer 01
04 pH Meter 01
05 Semi Micro Balance 01
06 Analytical Balance 01
| Now following instruments will be added for testing in PD laboratory.
S.No. 01
Instrument Name HPLC
Brand Water
Model ARC
Make USA
Quantity 02
HPLC Water ARC USA 02
S.No. 02
Instrument Name Karl Fisher
Brand Mettler Toledo
Model EVA V1
Make Switzerland
Quantity 01
| N/A | Approved | 30/04/2025 | Closed | Pharma | Actions plan for HPLC"
1) IQ, OQ and PQ will be performed. (PD)
2) SOP's will be developed. (PD)
3) Training will be provided to concern staff. PD
Actions plan for Karl Fisher"
1) IQ, OQ will be performed. (PD)
2) SOP's will be developed. (PD)
3) Training will be provided to concern staff. PD
| All actions related to HPLC and karl fisher have been completed.
| Timelines for HPLC
1) Done
2) Done
3) Done
Timelines for Karl fisher
1) Done
2) Apr-25
3) Apr-25
| 23/01/2025 | 20/04/2025 | Hamza Ahmed | Hamza Ahmed |
|
| CMP-0016-25 | 30/01/2025 | BD | Permanent | Minor | Change in responsibility of artwork management. |
• QC is responsible for artwork development, management and approval.
• QC is responsible for packaging material item codes opening. |
• BD will be responsible for artwork development, management and approval through manage artwork software.
• BD will be responsible for primary and secondary packaging material item codes opening.
• QC will be responsible for tertiary packaging related matters. | N/A | Approved | 28/02/2025 | Closed | Pharma | 01) IQ, OQ and PQ will be performed. Validation
02) SOP for artwork management will be revised and training will be provided to all concern staff. BD
03) SOP for review of artwork will be revised and training will be provided to all concern staff. QC
04) Training will be provided to concern staff. BD
| All actions have been completed.
1) Done
2) Done
3) Done
4) Done
| 1) May-25
2) May-25
3) May-25
4) May-25
| 30/01/2025 | 04/07/2025 | Hamza Ahmed | Hamza Ahmed |
|
| CMP-0017-25 | 30/01/2025 | SCM | Permanent | Minor | Change in Manufacturer name of M/s ZCL CHEMICAL LTD | We have approved MANUFACTURER by the name of M/s ZCL CHEMICAL LTD, for API “Fluvoxamine Maleate” listed in Vendor List .
Address: PLOT #. 3102/B, GIDC ESTATE ANKLESHWAR-393002, DIST: BHARUCH, GUJARAT, INDIA.
| This is to inform you that M/s ZCL CHEMICAL LTD Name has been Changed and New Name of manufacturer will be Cohance Lifesciences Limited while manufacturing site address will be remain same. | N/A | Approved | 30/04/2025 | Closed | Pharma | 1) Administrative documents will be submitted to QA. SCM
2) LIMS will be updated with new manufacturer name. QC
3) Vendor list will be updated based on receiving vendor documents. QA
| 1) Done
2) Done
3) Done
| 1) Feb-25
2) Apr-25
3) Apr-25
| 30/01/2025 | 04/07/2025 | Hamza Ahmed | Hamza Ahmed |
|
| CMP-0018-25 | 30/01/2025 | Engineering | Permanent | Minor | Replacement of existing dehumidifiers and addition of new AHUs to achieve better environmental conditions. | Currently in non-ceph pharma number of AHUs are opertioal with separate dehumidifiers to maintain the required conditions:
1) AHU-01, AHU-08, AHU-11, AHU-13, AHU-15, AHU-18, AHU-20, AHU-21, AHU-23 are serving with their dedicated dehumidifiers.
2) AHU-04 is serving in entire main corridor on fresh air and due to air pattern being cascade it serves fresh ambient air after processing from AHU in tablet compression, blistering & sachet sections which disturbs the environmental conditions of relevant areas.
3) AHU-16 is not connected with any dehumidifier.
4) Exhaust air from the area is taken from the common return duct i.e. returning back to AHU.
5) Currently AHU-21 i.e. serving in Blending-2 (A-MP-BLN-02) is fairly old unit which needs to be replaced.
6) Currently 500-ton chiller is serving all the AHUs with 7°C-8°C chilled water.
| To achieve better control of relative humidity (RH) and temprerature, following steps will be taken:
1) Existing dehumidifiers of AHU-01, AHU-08, AHU-13, AHU-15, AHU-18, AHU-20, AHU-21 and AHU-23 will be replaced with 02 new MUNTERS dehumidifiers MX2-80 which will be installed with their relevant AHUs namely AHU-24, AHU-25 for cooling ambient air then serving to dehumidifiers then serving dehumidified air to their relavant AHUs.
2) AHU-16 will also be served with one of new Munters dehumidifier.
3) AHU-04 supply will be cut-off from Blister-01 till Blister-03 in main corridor (doors will be installed to bifurcate) and from solid dosage corridor. New AHU-26 will be installed to serve the cut-off areas from AHU-04 with all the ducting and utilities work.
4) This new AHU-26 will also be served with one of new Munters dehumidifier.
5) Removal of existing AHU-21 and replacing with new more GMP compliant unit in the Blending-02 (A-MP-BLN-02).
6) Removal of dehumidifier from AHU-01 and connecting it with existing AHU-04 to treat the fresh air and subsequently serve better air quality(low RH air) where cascade air pattern is maintained.
7) It is planned to lay new chilled water piping to operate separate chiller i.e., 375 ton which will provide 5°C-6°C chilled water for areas with low humidity i.e, NMT 35% which are serving with AHUs namely; AHU-01, AHU-13, AHU-15, AHU-16, AHU-18, AHU-20, AHU-21, AHU-23 and new AHUs i.e., AHU-24, AHU-25 & AHU-26.
| RA-0007-25 | Approved | 30/06/2025 | In Progress | Pharma | 1) All actions will be track through project chart.
|
| 1) Timelines are mentioned in project chart.
| 30/01/2025 | 19/04/2025 | Hamza Ahmed | Hamza Ahmed |
|
| CMP-0019-25 | 01/02/2025 | Production | Permanent | Minor | Transferring of local products to Hoonga blister machines | 1) The products mentioned on the attached list are currently being blister on BM-350. The dimension of artwork of aluminum foil is 216mm and CFF is 218mm. | 1) The products mentioned on the attached list will be shifted to Hoonga blister machine. The dimension of artwork of aluminum foil will be 236mm and CFF is 244mm accordingly. | N/A | Approved | 30/09/2025 | In Progress | Pharma | 1) All actions will be track through project chart.
|
| 1) Timelines of each action are mentioned in project chart.
| 01/02/2025 | 21/04/2025 | Hamza Ahmed | Hamza Ahmed |
|
| CMP-0020-25 | 01/02/2025 | Production | Permanent | Minor | Transferring of products to Hoonga blister machine | The 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 244mm. 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) | N/A | Approved | 31/08/2025 | In Progress | Pharma | 1) All actions will be track through project chart.
|
| 1) Timelines of each action are mentioned in project chart.
| 01/02/2025 | 21/04/2025 | Hamza Ahmed | Hamza Ahmed |
|
| CMP-0021-25 | 01/02/2025 | Production | Permanent | Minor | Elimination of physical tests from Finished product specifications | Currently, the following physical tests are included as part of the finished product specifications.
1. Thickness
2. Hardness
3. Friability
4. Diameter
5. Length
6. Width | It is proposed to eliminate the physical tests from the finished product testing specifications. | N/A | un approved | | Closed | Pharma |
| Change has been closed without implementation.
|
| 01/02/2025 | 15/04/2025 | Hamza Ahmed | Hamza Ahmed |
|
| CMP-0022-25 | 01/02/2025 | QC | Permanent | Minor | Breakdown of particle size distribution | Currently, PSD was being performed via particle size distribution (Mastersizer 3000) | It is proposed that QC entered the PSD results in LIMS as per manufacturer's COA and then released the raw materials. | N/A | Approved | 30/09/2025 | In Progress | Pharma | 1) PSD results of manufacturer will be added in LIMS. QC
2) Calibration of particle size distribution will be performed after rectification. QC
| 1) Done
| 1) Immediate
2) Aug-25
| 01/02/2025 | 15/04/2025 | Hamza Ahmed | Hamza Ahmed |
|
| CMP-0023-25 | 04/02/2025 | PD | Permanent | Major | Addition of GHL-3/10 High Speed Mixer Granulator with brimful capacity of 3 liters.
Addition of DLP-MINI Fluid Bed Granulator/Coater/Dryer of capacity 1000g.
Addition of LGS-5 Dry Granulator.
| Currently PD didn’t have GHL-3/10 High Speed Mixer Granulator.
Currently PD didn’t have DLP-MINI Fluid Bed Granulator/Coater/Dryer.
Currently PD didn’t have LGS-5 Dry Granulator.
| It is proposed to installed GHL-3/10 High Speed Mixer Granulator with brimful capacity of 3 liters in PD area.
It is proposed to installed DLP-MINI Fluid Bed Granulator/Coater/Dryer in PD area.
It is proposed to installed PD have equipped LGS-5 Dry Granulator in PD area.
| N/A | Approved | 31/07/2025 | In Progress | Pharma | 1) IQ, OQ and PQ of all equipment’s will be performed.
2) SOP’s of all equipment’s will be developed.
3) Training will be provided to all concern staff.
4) List of Equipment will be revised to in-cooperate the new equipment’s.
|
| 1) July-25
2) July-25
3) July-25
4) July-25
| 04/02/2025 | 16/04/2025 | Hamza Ahmed | Hamza Ahmed |
|
| CMP-0024-25 | 07/02/2025 | BD | Temporary | Minor | Supply of products in Zambia against Special Import Permit. | The below-mentioned products have not been supplied in Zambia yet:
1. Avsar (Amlodipine + Valsartan) 10mg + 160mg Tablets | 2x7’s
2. Avsar Plus (Amlodipine + Valsartan + Hydrochlorothiazide) 10mg + 160mg + 12.5mg Tablets | 4x7’s
3. Klevra (Levetiracetam) 500mg Tablets | 3x10’s
| These products are planned for supply in Zambia against Special Import Permit.
Note:
• Local packaging will be used.
• MRP will not be printed.
• Shelf life will be same as local market.
| N/A | Approved | 31/05/2025 | In Progress | Pharma | 1) Launch of Avsar 160/10mg in Zambia. BD
2) Launch of Avsar Plus 160/10/12.5mg in Zambia. BD
3) Launch of Klevra 500mg in Zambia. BD
4) Special import permit is required for commercialization. RA
5) FG code will be opened. SCM
6) BOM and BPR will be revised. QA
| 2) Done
3) Done
4) Special import permit of Klevra 500mg and Avsar Plus 160/10/12.5mg has been completed.
5) Done
6) BOM of and all three products has been created while the BPR of Klevra 500mg and Avsar Plus 160/10/12.5mg Tablet has been prepared.
| 1) May-25
2) May-25
3) May-25
4) May-25
5) Apr-25
6) May-25
| 07/02/2025 | 15/04/2025 | Hamza Ahmed | Hamza Ahmed |
|
| CMP-0025-25 | 10/02/2025 | SCM | Permanent | Major | Additional source induction of linagliptin | We have approved sources for Linagliptin as M/s JIANGSU YONGAN & M/s Lee Pharma. | we intend to induct one more source M/s Fuxin Long Rui Pharmaceuticals Co; Ltd, Fluoride Industrial Park, Fumeng County (YI Ma Tu), Fuxin City, Liaoning Province-123000, China. | N/A | Approved | 31/12/2025 | In Progress | Pharma | 1) Source approval documents will be submitted to QA. SCM
2) Procurement of material form new source. SCM
3) Vendor list will be update. QA 4) Source name will be added in LIMS. QC
5) Process validation will be performed. QA
6) Stability will be performed on validation batches. QC
| 1) Source has been approved.
2) Procurement has been done.
3) Done
4) Done
| 1) Feb-25
2) May-25
3) Feb-25
4) May-25
5) Dec-25
6) Dec-25
| 10/02/2025 | 02/07/2025 | Hamza Ahmed | Hamza Ahmed |
|
| CMP-0026-25 | 10/02/2025 | SCM | Permanent | Minor | Change in batch size of Aprep Cap. 80mg/125mg Combo, Aprep Cap. 80mg Combo, and Aprep Cap. 125mg Combo. |
Currently batch size of following products is mentioned below:
1. Aprep Cap. 80mg/125mg Combo is 8000 packs per batch.
2. Aprep Cap. 80mg Combo is 16480 Caps per batch
3. Aprep Cap. 125mg Combo is 8,240 Caps per batch | It is proposed to revise the batch size of below mentioned products:
1. Aprep Cap. 80mg/125mg Combo is 4,000 packs per batch.
2. Aprep Cap. 80mg Combo is 8,240 Caps per batch
3. Aprep Cap. 125mg Combo is 4,120 Caps per batch
| N/A | Approved | 30/06/2025 | In Progress | Pharma | 1)Bom will be update in SAP for both Aprep 80mg combo and Aprep 125mg combo capsule at SFG stage and for Aprep Combo 80/125mg capsule at FG Stages. QA
2)Batch Documents of Aprep 80mg Capsule and Aprep 125mg Capsule and for Aprep Combo 80/125mg capsule will be revised. QA
3)Process Validation will be performed on Apred 80mg and on Aprep 125mg Capsule due to decreased in batch size. QA
4)QC will perform the stability on validation batches of Aprep 80mg and Aprep 125mg capsule. QC
| 1) All BOM's have been revised.
2) Batch Documents have been revised.
| 1)March-25
2)March-25
3)March-26
4)March-26
| 10/02/2025 | 17/04/2025 | Hamza Ahmed | Hamza Ahmed |
|
| CMP-0027-25 | 14/02/2025 | QC | Permanent | Minor | Change in specification of raw material Dapagliflizin from in-house specification to USP – 43.
| Currently, the specifications for the API raw material (Dapagliflozin) from the manufacturers—Fuxin Longrui, Jiangsu Yongan, Weifang Hishine, and Zhejiang Hongyuan—are based on in-house claims. | It is proposed to revise the specification of Dapagliflozin from in-house specification to USP – 43. | N/A | Approved | 31/08/2025 | In Progress | Pharma | 1)Specifications agreement as per USP will be submitted to SCM. QC
2)Updated specification agreement will be arranged from all vendors. SCM
3)Updated specifications agreement will be intimated in relevant authorities. RA
4)Testing method will be revised as per USP specs. QC
5)Standards and supply column will be arranged. QC
6)API verification will be performed. QC
7)Standardization will be performed. QC
| 1) Done
| 1)March-25
2)Aug-25
3)Aug-25
4)Aug-25
5)June-25
6)June-25
7)July-25
| 14/02/2025 | 05/07/2025 | Hamza Ahmed | Hamza Ahmed |
|
| CMP-0028-25 | 14/02/2025 | PD | Permanent | Major | New launch product Naproxen / Esomeprazole 500mg/20mg Tablet. | Product development activities of generic Naproxen / Esomeprazole 500mg/20mg Tablet has been completed. | It is proposed to commercialize Naproxen / Esomeprazole 500mg/20mg Tablet in pharmevo facility | RA-0009-25 | Approved | 31/05/2026 | In Progress | Pharma | 1)Trial document are required. PD
2)Stability study documents are required. PD
3)Contaiment approach report is required. PD
4)Cleanability report is required. PD
5)Technology transfer Protocol (for process) is required. PD
6)Technology transfer protocol (for analytical testing) is required. PD
7)Procurment of required raw material. SCM
8)Artwork will be developed and approved. BD
9)Item codes will be opened for new developed artwork. BD
10)Procurment of packaging material. SCM
11)Analytical Testing Method will prepare and update on LIMS. QC
12)BOM will create in SAP. QA
13)Batch Document (BDR, BMR, BYS, BPR) will be prepared. QA
14)Routing will be create in SAP. Production
15)Planning of product launch for commercial. BD
16)Process validation will be perform. QA (VAL)
17)Product will be charge on stability. QC
18)Regulatory approval required before launch. RA
| 1) Done
2) Done
| 1)Done
2)Done
3)Apr-25
4)Apr-25
5)May-25
6)May-25
7)Apr-25
8)Mar-25
9)Mar-25
10)May-25
11)May-25
12) May-25
13) May-25
14) May-25
15) May-25
16) May-26
17)May-26
18)March-25
| 14/02/2025 | 19/04/2025 | Hamza Ahmed | Hamza Ahmed |
|
| CMP-0029-25 | 14/02/2025 | PD | Permanent | Major | New launch product Pregablin CR 330mg , 165mg and 82.5mg Tablet. | Product development activities of generic Pregablin CR 330mg , 165mg and 82.5mg Tablet has been completed. | It is proposed to commercialize Pregablin CR 330mg , 165mg and 82.5mg Tablet in pharmevo facility. | RA-0010-25 | Approved | 31/03/2026 | In Progress | Pharma | 1)Trial document are required. PD
2)Stability study documents are required. PD
3)Contaiment approach report is required. PD
4)Cleanability report is required. PD
5)Technology transfer Protocol (for process) is required. PD
6)Technology transfer protocol (for analytical testing) is required. PD
7)Procurment of required raw material. SCM
8)Artwork will be developed and approved. BD
9)Item codes will be opened for new developed artwork. BD
10)Procurement of packaging material. SCM
11) Regulatory approval required before launch. RA
12)Analytical Testing Method will prepare and update on LIMS. QC
13)BOM will create in SAP. QA
14)Batch Document (BDR, BMR, BYS, BPR) will be prepared. QA
15)Routing will be create in SAP. Production
16)Planning of product launch for commercial. BD
17)Process validation will be performed. QA (VAL)
18)Product will be charge on stability. QC
| Actions are completed for all strengths are mentioned below:
1) Trail has been completed.
2) Done
7) Done
11) Regulatory approval has been received.
| Timelines for pregabalin CR 330:
1)10Mar-25
2)Apr-25
3)Apr-25 (Extended till July-25)
4)Apr-25 (Extended till July-25)
5)May-25 (Extended till Oct-25)
6)May-25 (Extended till Oct-25)
7)Inventory Item
8)Mar-25 (Extended till July-25)
9)Mar-25 (Extended till July-25)
10)May-25 (Extended till Sep-25 to Oct-25)
11)June-25
12)July-25(Extended till Oct-25)
13)July-25(Extended till Nov-25)
14)July-25(Extended till Nov-25)
15)July-25(Extended till Nov-25)
16)July-25(Extended till Nov-25)
17)Mar-26(Extended till July-26)
18)Mar-26(Extended till July-26)
Timelines for pregabalin CR 165 and 82.5mg are same:
1)Done
2)Done
3)Apr-25 (Extended till July-25)
4)Apr-25 (Extended till July-25)
5)May-25 (Extended till Oct-25)
6)May-25 (Extended till Oct-25)
7)Inventory Item
8)Mar-25 (Extended till July-25
9)Mar-25 (Extended till July-25
10)May-25 (Extended till Sep-25 to Oct-25)
11)June-25
12)July-25 (Extended till Oct-25)
13)July-25 (Extended till Nov-25)
14)July-25 (Extended till Nov-25)
15)July-25 (Extended till Nov-25)
16)July-25 (Extended till Nov-25)
17)Mar-26 (Extended till July-26)
18)Mar-26 (Extended till July-26)
| 14/02/2025 | 05/07/2025 | Hamza Ahmed | Hamza Ahmed |
|
| CMP-0030-25 | 19/02/2025 | BD | Permanent | Minor | Launch of New Products in Afghanistan. | Products mentioned in the attached list are not launched in Afghanistan yet. | These products are planned for launch in Afghanistan. | N/A | Approved | 31/05/2025 | In Progress | Pharma | 1) Performa invoice will be required prior to launch. RA
2)Product Launch in Afghanistan. BD
3)FG codes will be opened. SCM
4)BOM will create on SAP. QA
5)BPR will be prepared. QA
| 3) FG code has been opened.
| 1)Aug-25
2)Aug-25
3)May-25
4)Aug-25
5)Aug-25
| 19/02/2025 | 05/07/2025 | Hamza Ahmed | Hamza Ahmed |
|
| CMP-0031-25 | 19/02/2025 | BD | Permanent | Minor | Launch 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/A | Approved | 31/05/2025 | In Progress | Pharma | 1) Product launch in Cambodia. BD
2)Development and approval of artwork. BD
3)Item codes of packaging materials will be opened. BD
4)Fg codes will be opened. SCM
5)BOM will be create bin SAP. QA
6)BPR will be prepared. QA
7)Procurment of Packaging material. SCM
8)Specification will be developed in LIMS. QC
| 2) Artwork has been developed.
3) Item code has been opened.
4) FG codes has been opened.(Done)
| 1)May-25 (Extension till Nov-25)
2)April-25
3)April-25
4)Mar-25
5)May-25 (Extension till Nov-25)
6) May-25 (Extension till Nov-25)
7)May-25 (Extension till Oct-25)
8)May-25 (Extension till Nov-25)
| 19/02/2025 | 04/07/2025 | Hamza Ahmed | Hamza Ahmed |
|
| CMP-0032-25 | 24/02/2025 | SCM | Permanent | Minor | Change in Manufacturer name | We have approved Manufacturer by the name of Iberchem for Banana Flavor.
Address: Scentium Flavours S.L.U. Avada. De Holanda. Parc. 12/14 – 16 80840 Alhama de Murcia Spain.
| It is to proposed that Manufacturer name has been changed to Scentium from Iberchem while the Manufacture site/material will remain same.
Address: Scentium Flavours S.L.U. Avada. De Holanda. Parc. 12/14 – 16 80840 Alhama de Murcia Spain.
| N/A | Approved | 28/02/2025 | Closed | Pharma | 1)Vendor List will be updated. QA
2)Manufacturer name will be revised in LIMS. QC
| 1) Name of manufacturer has been revised in vendor list.
2) Done
| 1) Done
2) Done
| 24/02/2025 | 20/04/2025 | Hamza Ahmed | Hamza Ahmed |
|
| CMP-0033-25 | 24/02/2025 | PD | Permanent | Major | Increase in Batch size and change in manufacturing method of Evorox Suspension. | Currently Evorox Suspension batch size is 100.00Kg.
The Evorox Suspension is currently being manufactured as Wet granulation method using Manesty mixer and drum blender.
| It is proposed to scaleup the batch size to 200.00Kg.
In manufacturing method of Evorox Suspension, it is proposed to add sieving of sucrose using Fitz mill and mixing with API then final blending in double cone blender.
| N/A | Approved | 30/09/2025 | In Progress | Pharma | 1)PD will perform the trial. PD
2)Variation will be submitted and approval to be sought prior to implementation. RA
3)SFG anf FG BOM and Batch documents will be required. QA
4)Process validation will be revised. QA
5)stability will be performed. QC
| 1) Done
3) SFG, FG and Batch document have been revised.
| 1) Done
2) Sep-25
3) Feb-25
4) Dec-25
5) Dec-25
| 24/02/2025 | 21/04/2025 | Hamza Ahmed | Hamza Ahmed |
|
| CMP-0034-25 | 24/02/2025 | QC | Permanent | Minor | Addition of new brusting strength tester instrument in QC Packaging Lab | Currently QC packaging lab have no instrument to check the brusting strengths of paper boards, card boards, corrugated boxes and boxes, to check the ability of corrugated box while during packing, transportation, loaded, un-loaded, hit, torn during the process. | It is proposed that following instruments will be installed in QC packaging laboratory.
S.No. Instrument Lab
01 Bursting Strength tester
Quantity Make
01 Crucial Supplies | N/A | Approved | 30/06/2025 | In Progress | Pharma | 1)IQ and OQ will be performed through vendor. QC
2)Calibration will be performed. QA
3)Calibration list will be updated. QA
4)SOP will be prepared. QC
5)QC instrumentation list will be revised. QC
|
| 1)Aug-25
2)Sep-25
3)Sep-25
4) Aug-25
5) Aug-25
| 24/02/2025 | 04/07/2025 | Hamza Ahmed | Hamza Ahmed |
|
| CMP-0035-25 | 24/02/2025 | QC | Permanent | Minor | Addition of new Tensile strength Instruments in QC Packaging Lab | Currently QC packaging lab have no instrument to check the tensile strength, and elasticity of packaging materials like cold formable foil, Blister foil, PVC, PVC, PVDC, Triplex foil. | It is proposed that following instrument will be installed in QC Packaging Laboratory.
S.No. Instrument Lab
01 Tensile Blister Strength
Quantity Make
01 Crucial Supplies | N/A | Approved | 30/06/2025 | In Progress | Pharma | 1)IQ and OQ will be performed through vendor. QC
2)Calibration will be performed. QA
3)Calibration list will be updated. QA
4)SOP will be prepared. QC
5)QC instrumentation list will be revised. QC
|
| 1)Aug-25
2)Sep-25
3)Sep-25
4) Aug-25
5) Aug-25
| 24/02/2025 | 04/07/2025 | Hamza Ahmed | Hamza Ahmed |
|
| CMP-0036-25 | 27/02/2025 | Production | Permanent | Minor | Batch size upgradation and transfer of product to granulation 01 | Following batches are manufactured in G2 area need to be shifted in G1 area, to increase the batch size.
1. Aireez 10mg Tab
2. Erli 25mg Tab
3. Erli 10mg Tab
4. Anplag 90mg Tab | List provided with the details of batches to be updated.
Product name :Aireez 10mg Tab
Current batch
size : 40Kg
Proposed batch: 80Kg
size
Equipment: G1, V-Blender, and BG 150Coater
Product name :Erli 25mg Tab
Current batch
size : 25Kg
Proposed batch: 100Kg
size
Equipment: G1, V-Blender, and BG 150Coater
Product name :Erli 10mg Tab
Current batch
size : 50Kg
Proposed batch: 100Kg
size
Equipment: G1, V-Blender, and BG 150Coater
Product name :Anplag 90mg Tab
Current batch
size : 30Kg
Proposed batch: 90Kg
size
Equipment: G1, V-Blender, and BG 150Coater
| N/A | Approved | 31/03/2026 | In Progress | Pharma | 1) SFG and FG BOM will be revised. QA
2) Batch Documents will be revised. QA
3) Process validation will be performed. Validation
4) Stability will be conducted on PV batches.
|
| 1) Sep-25
2) Sep-25
3) Mar-26
4) Mar-26
| 27/02/2025 | 20/04/2025 | Hamza Ahmed | Hamza Ahmed |
|
| CMP-0037-25 | 27/02/2025 | QC | Permanent | Minor | Addition of 02 new pharmaceutical refrigerators in QC Lab | QC currently have the following number of refrigerators for standards and samples storage.
S. No. 01
Equipment Name Refrigerator
Quantity 02
| It is suggested that two new pharmaceutical refrigerators be installed in the QC Laboratory, while the existing refrigerators will become idle and be moved to a non-GMP area.
S. No. 01
Equipment Name Refrigerator
Quantity 02
| N/A | Approved | 30/04/2025 | Closed | Pharma | 1)IQ and OQ will be performed through vendor. QC
2)PQ will be performed. Val
3)SOP will be prepared. QC
4)Instrument list will be revised. QC
| 1) Qualification has been performed.
2) Done
3) SOP has been prepared.
4) Instrument list has been revised.
| 1)Apr-25
2)Apr-25
3)Apr-25
4)Apr-25
| 27/02/2025 | 02/07/2025 | Hamza Ahmed | Hamza Ahmed |
|
| CMP-0038-25 | 27/02/2025 | SCM | Permanent | Minor | Change in manufacturer name | We have approved manufacturer by the name of M/s Sudeep Pharma Pvt Ltd; Address: 129/1A, G.I.D.C. Estate, Nandesari, Vodobara-391 340, Gujarat. | It is proposed that manufacturer name has been changes to M/s Sudeep Pharma Ltd . Address: while the manufacturer site/mserial will remain will same. | N/A | Approved | 31/05/2025 | In Progress | Pharma | 1)Updated administrative documents are required. SCM
2)Vendor list will be updated. QA
3)Manufacturer name will be revised in LIMS
|
| 1)May-2025
2)May-2025
3)May-2025
| 27/02/2025 | 20/04/2025 | Hamza Ahmed | Hamza Ahmed |
|
| CMP-0039-25 | 27/02/2025 | QC | Permanent | Minor | Addition of new instrument in QC Laboratory (Non Ceph Area). | Currently QC lab (Non ceph) has following quantity of Analytical Weighing balance, Semi micro balance, Karl fischer, viscometer and pH meter and dissolution apparatus for Raw material, Semi-finished, Finished product and Stability testing.
S. No. 01
Instrument Name Analytical weighing balance
Quantity 02
Make Metler Toledo
S. No. 02
Instrument Name Semi micro balance
Quantity 01
Make Metler Toledo
S. No. 03
Instrument Name Karl fischer
Quantity 01
Make Metler Toledo
S. No. 04
Instrument Name Dissolution apparatus
Quantity 07
Make Pharma test
S. No. 05
Instrument Name Viscometer
Quantity 01
Make Brooksfield
S. No. 06
Instrument Name pH meter
Quantity 01
Make Metler Toledo and Ino lab
| It is proposed that following instruments will be installed in QC Laboratory.
S. No. 01
Instrument Name Analytical weighing balance
Quantity 01
Make Metler Toledo
S. No. 02
Instrument Name Semi micro balance
Quantity 02
Make Metler Toledo
S. No. 03
Instrument Name Karl fischer
Quantity 01
Make Metler Toledo
S. No. 04
Instrument Name Dissolution apparatus
Quantity 05
Make Sortax
S. No. 05
Instrument Name Viscometer
Quantity 01
Make Brooksfield
S. No. 06
Instrument Name pH meter
Quantity 02
Make Metler Toledo
| N/A | Approved | 31/12/2025 | In Progress | Pharma | 1)IQ, OQ of all instruments will be performed. QC
2)Calibration of all instrument will be performed. QC
3)Instrument list will be updated. QC
4)Calibration list will be update. QA
5)SOP of all instruments will be prepared. QC
|
| 1)Sep-25
2)Sep-25
3)Sep-25
4)Dec-25
5)Sep-25
| 27/02/2025 | 20/04/2025 | Hamza Ahmed | Hamza Ahmed |
|
| CMP-0040-25 | 27/02/2025 | SCM | Temporary | Minor | Usage of API Dapagliflozin Propanediol Monohydrate lot no 0000046976 with particle size 436µm | QC has rejected the material Dapagliflozin Propanediol Monohydrate lot no 0000046976 because out of specification result was observed in particle size.
Actual Particle Size D(90): 50µm Observed particle Size :436µm
| It is proposed to used the API Dapagliflozin lot no 0000046976 with particle size 436µm. | N/A | Approved | 31/05/2025 | In Progress | Pharma | 1)GRN will be create in SAP. WH
2)QC will released the material and immediately hold till the satisfactory results of PD trial. QC
3)Trial will be performd on Dapwiz Plus XR Tablet. PD
4)After Satisfactory results batch will be proceed for the commercial batch. Production
| 1) GRN has been created.
2) Done
| 1) Apr-25
2) Apr-25
3) July-25
4) July-25
| 27/02/2025 | 05/07/2025 | Hamza Ahmed | Hamza Ahmed |
|
| CMP-0041-25 | 27/02/2025 | QC Micro | Temporary | Minor | Induction of vortex meter in quality control Cephalosporin and Non-Cephalosporin Microbiology Laboratories. | Currently mixing of samples is done manually in Microbiology Laboratory. | It is proposed to add three cortex mixer ACE GmbH Model No. MX-S details are below:
Name of equipment Vortex mixer
Qty for non-cep h Micro lab: 02
Qty for ceph Micro lab: 01 | N/A | Approved | 31/03/2025 | Closed | Pharma | 1) SOP will be prepared. Micro
2) Training will be provided to concern staff.
| All actions have been completed.
1) Done
2) Done
| 1) Mar-25
2) Mar-25
| 27/02/2025 | 20/04/2025 | Hamza Ahmed | Hamza Ahmed |
|
| CMP-0042-25 | 03/03/2025 | Production | Permanent | Minor | Continuous Nitrogen purging during Sachet filling in Vertical Sachet filling machine (Non-Ceph Production). | Currently, during filling of sachets we are doing post purging of nitrogen in products filled in Four Non-Ceph Production. | It is proposed to induct continuous nitrogen purging during Sachet filling on Vertical Sachet filling machine installed in Non-Ceph Production. | N/A | Approved | 30/04/2025 | In Progress | Pharma | 1)Nitrogen purging cylinder will be installed in both sachet machines. Engineering
2)Switch will be provided in both sachet machine, as the continuous nitrogen purging stops in the sachet machine, the machine will also automatically stop.. Engineering
3)Continuous nitrogen purging will be verified and qualified. Validation
| 1) Done
2) Done
| 1) Apr-25
2) Apr-25
3) Apr-25(Extended till Aug-25)
| 04/03/2025 | 05/07/2025 | Hamza Ahmed | Hamza Ahmed |
|
| CMP-0043-25 | 03/03/2025 | SCM | Permanent | Major | Additional source induction PVC | We are currently procuring Rigid PVC Transparent from M/s. Nuplas Industries Ltd & Liveo Research Singapore PTE Ltd. | We intend to induct one more source M/s. Zibo Zhongnan Pharmaceutical Packaging Material Co., Ltd Address:No.1966 Hongda road, Linzi Economic development Zone. Zibo City, Shangdong Province, China | N/A | Approved | 31/03/2026 | In Progress | Pharma | 1) Source approval documents are required. SCM
2) Procurement of material from new vendor. SCM
3)Vendor list will be revised. QA
4)Vendor name will be added in LIMS. QC
| 1) Done
3) Vendor list has been updated.
| 1)Done
2)Mar-2026
3)Apr-25
4)May-25
| 04/03/2025 | 19/04/2025 | Hamza Ahmed | Hamza Ahmed |
|
| CMP-0044-25 | 28/02/2025 | QC | Permanent | Major | Additional source induction of Sumatriptan Succinate | We are currently procuring Sumatriptan Succinate from M/s. Hunan Jiuidian Hongyang Pharmaceutical Co. Ltd. | We intend to induct one more source M/s. Smilax Laboratories Limited
Address: Plot No.12/A, Phase-III, IDA Jeedimetla , Hyderabad -500 055, Telangana ,INDIA
| N/A | Approved | 30/06/2026 | In Progress | Pharma | 01)Variation approval will be required prior to implementation of new source. RA
02)Source approval documents are required. SCM
03)Procurement of material from new source. SCM
04)Vendor list will be updated. QA
05)Source name will be added in LIMS. QC
06)QC will hold the material in SAP after released until the variation approval. QC
07) Process validation will be performed. QA
08) Stability study will be performed. QC
| 2. Source has been approved. (Done)
| 1) Jun-26
2) Mar-25
3) Dec-25
4) Aug-25
5) Sep-25
6) Dec-25
7) May-26
8) May-26
| 04/03/2025 | 04/07/2025 | Hamza Ahmed | Hamza Ahmed |
|
| CMP-0045-25 | 06/03/2025 | BD | Permanent | Minor | Change in aluminum foil of SPC orders | Currently foil without SPC logo and instructions is being used for the below mentioned products in srilanka
S.No Product Name Product Code Material Name Material Code
01 Inosita 50mg 1400000978 Alu Foil 1200001542
02 Arbi 150mg 1400000939 Alu Foil 1200001563 | It is proposed to used the foil with SPC logo and instructions in Sri Lanka. | N/A | Approved | 31/08/2025 | In Progress | Pharma | 1)Development and approval of artwork.BD
2)New item code will be open. BD
3)BOM will be revised in SAP. QA
4)Procurement of A/F as per revised artwork. SCM
5) LIMS specification will be revised. QC
| Arbi 150mg Tab:
1) Done
2) Done
3) Done
5) Done
Inosita 50mg Tab:
1) Done
2) Done
3) Done
5) Done
| Action plan for Inosita 50 mg Tablet:
1) Jun-25
2) Jun-25
3) Jun-25
4) Aug-25
5) Jun-25
Action plan for Arbi 150 mg Tablet:
1) Apr-25
2) Apr-25
3) Apr-25
4) Aug-25
5) May-25
| 06/03/2025 | 04/07/2025 | Hamza Ahmed | Hamza Ahmed |
|
| CMP-0046-25 | 06/03/2025 | QA | Permanent | Minor | Development of Approved Vendor list in SAP | Currently, the vendor list is manually developed and maintained by the QA department. | Develop an approved vendor list in SAP, systematically linking materials to approved manufacturers. Any addition, modification, blocking, or deletion of an approved manufacturer will be carried out by QA with endorsement from the Supply Chain Department. | N/A | Approved | 31/07/2025 | In Progress | Pharma | 01) Developed an approved manufactured list Iin SAP. IT
02) Subjected change will be verified. Validation
03) SOP of “Supplier Management System” QCG/2/037 will be revised. QA
04) Training will be provided to all stakeholders. QA
|
| 1) July-25
2) July-25
3) July-25
4) July-25
| 08/03/2025 | 21/04/2025 | Hamza Ahmed | Hamza Ahmed |
|
| CMP-0047-25 | 06/03/2025 | QA | Permanent | Major | Modification of the 2D Barcode Scanning System to Ensure Compatibility with the DRAP Barcode Scanner | Currently, 2D barcodes are printed on pharmaceutical product unit cartons, which can be scanned using the "Pharma Trax Scanner," provided by the supplier of 2D printing machines. | Develop a system to ensure that the 2D barcode on unit cartons is scannable with the "DRAP Barcode Scanner" during online production. The scanning records must be maintained along with batch printing records. | N/A | Approved | 30/06/2025 | In Progress | Pharma | 1)Pharma Trax software will be update to incorporate the DRAP app for barcode scanner. Production
2)Change in software will be verified. Validation
3)SOP will be revised. Production
| 1) Done
3) Done
| 1) Jun-25
2) July-25
3) Jun-25
| 08/03/2025 | 04/07/2025 | Hamza Ahmed | Hamza Ahmed |
|
| CMP-0048-25 | 07/03/2025 | SCM | Permanent | Major | Additional source induction for HPMC capsule for Dexlansoprazole Size 2 & Size 3
|
At present HPMC capsule for Dexlansoprazole Size 2 & Size 3, is being procured from our approved one source M/s Jiangsu Lefan Capsule Co. Ltd
| We intend to induct one more source M/s. Unicapsule (Jinagsu) Co Ltd, Address: Building 21,No.20,Xiushui Road.Pharmaceutical-High-tech Industrial Development Zone,TaiZhou CityJiangsu,P.R.China | N/A | Approved | 31/07/2026 | In Progress | Pharma | 1)Source approval documents are required. SCM
2)Procurment of material from new source. SCM
3)Vendor List will be updated. QA
4)Process validation will be performed. QA
5)Source name will be added in LIMS. QC
6)Stability study will be performed. QC
|
| 1) Aug-25
2) Dec-25
3) Aug-25
4) July-26
5) Aug-25
6) July-26
| 08/03/2025 | 05/07/2025 | Hamza Ahmed | Hamza Ahmed |
|
| CMP-0049-25 | 07/03/2025 | BD | Permanent | Minor | Launch of New Products in American territories (Export group-S). | The product mentioned in the attached list are not launched in these territories yet. | These products are planned to be launched. | N/A | Approved | 31/07/2025 | In Progress | Pharma | 01) Planning of product launch for commercial. BD
02) Development and approval artwork(U/C, A/F and D/I.
BD
03) Item code will be opened. BD
04 FG code will be opened. SCM
05) Registration letter is required before commercialization. RA
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 LIMS. QC
|
| Action plans for products other than zibes 10mg Tab:
1) July-25
2) May-25
3) May-25
4) Apr-25
5) Done
6) July-25
7) July-25
8) July-25
9) Aug-25
Action plans for zibes 10mg Tab:
1) July-25
2) May-25
3) May-25
4) Apr-25
5) Mar-25
6) July-25
7) July-25
8) July-25
9) Aug-25
| 08/03/2025 | 20/04/2025 | Hamza Ahmed | Hamza Ahmed |
|
| CMP-0049-25 | 07/03/2025 | BD | Permanent | Minor | Launch of New Products in French West Africa. | The products mentioned in the attached list are not launched in French West Africa yet. | These products are planned for launch in French West Africa. Artwork of A/F, U/C and D/I will remain same for all the countries. | N/A | Approved | 31/07/2025 | In Progress | Pharma | 01) Planning of product launch for commercial. BD
02) Development and approval artwork (U/C, A/F and D/I. BD
03) Item code will be opened. BD
04) FG code will be opened. SCM
05) Registration letter is required before commercialization. RA
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 LIMS. QC
| 2) Artwork has been developed.
3) Item code will be opened.
5) Done
| Action plans for all products:
1) Done
2) July-25
3) May-25
4) May-25
5) Apr-25
6) July-25
7) July-25
8) July-25
9) Aug-25
Action plans for zibes 10mg Tab:
1) July-25
2) May-25
3) May-25
4) Apr-25
5) Mar-25
6) July-25
7) July-25
8) July-25
9) Aug-25
| 08/03/2025 | 04/07/2025 | Hamza Ahmed | Hamza Ahmed |
|
| CMP-0051-25 | 12/03/2025 | PD | Permanent | Major | New launch product Roxadustat 70mg, 100mg, 150mg Tablet. | Product and development activities of generic Roxadustat 70mg, 100mg, 150mg Tablet has been completed. | It is proposed to commercialize Roxadustat 70mg, 100mg, 150mg Tablet in pharmevo facility. | RA-0012-25 | Approved | 31/03/2026 | In Progress | Pharma | 1)Trial document are required. PD
2)Stability study documents are required. PD
3)Contaiment approach report is required. PD
4)Cleanability report is required. PD
5)Technology transfer Protocol (for process) is required. PD
6)Technology transfer protocol (for analytical testing) is required. PD
7)Regulatory approval required before launch. RA
8)procurment of required raw material. SCM
9)Artwork will be developed and approved. BD
10)Item codes will be opened for new developed artwork. BD
11)Procurment of packaging material. SCM
12)Analytical Testing Method will prepare and update on LIMS. QC
13)BOM will create in SAP. QA
14)Batch Document (BDR, BMR, BYS, BPR) will be prepared. QA
15)Routing will be create in SAP. Production
16)Planning of product launch for commercial. BD
17)Process validation will be perform. QA(VAL)
18)Product will be charge on stability. QC
19) Source approval documents will be submitted to QA. SCM
| 1) Done
2) Done
3) Done
4) Done
5) Done
6) Done
7 ) Done
| 1) Done
2) Done
3) May-25
4) May-25
5) May-25
6) May-25
7) Jun-25
8) July-25
9) Jun-25-Jul-25
10) Jun-25-Jul-25
11) July-25
12) July-25
13) July-25
14) July-25
15) July-25
16) July-25
17) Mar-26
18) Mar-26
19) Jun-25
| 12/03/2025 | 04/07/2025 | Hamza Ahmed | Hamza Ahmed |
|
| CMP-0052-25 | 14/03/2025 | SCM | Permanent | Major | Development of document and data control system in software | QA department is responsible for the document and data control system in which all the documentations at factory and head office e.g. Standanrd Operating Procedure, Job Descrption, Organograms, Plans, Lists, Site Master File, Layouts, formats, logbooks etc are being controlled in line with the international guidelines. As per SOP for Document and Data Control Management (QAG/2/059) all documents are controlled, distributed and retrieved after approval. Similarly, in accordance with SOP for SOP (QAG/2/056), departmental procedures are developed as per outlined approved format, JDs and Organograms are developed and controlled against the approved formats as per SOP for Organogram & JDs (QAG/2/067) and Logbooks are issued and retrieved as per SOP for Logbook Management System (QAG/2/080).
Currently all afore-mentioned documents are being developed and controlled manually by signing and stamping over master copies except the master lists, which are maintained in excel sheets in order to record assigned numbers to the particular documents.
The original hard copies of all the SOPs, formats, JDs, organgorams, lists, plans, manuals, policies are being maintained by QA as master documents while the copies of these documents are provided to and held by the relevant departments as being owner or stakeholder.
Periodic reviews and revisions of the documents repeat the cycle of controlling and distribution of these docuemnts in hard copies generating a bulk of papers.
| It is proposed to develop a software which will provide an online access to all the users for developing, revising or reviewing their documents. In this software standard formats of these documents may be uploaded on which every user will develop their documents for uniformity of the documentation. For creation or revising each department will have an access of the software, moreover, reviewers and approvers will also perform their task online.
This software should have defined access levels and audit trails in order to ensure the integrity of data being provided and record the changes. Access levels will be defined for providing the rights of different activities such as input data, edit data, review data, printing, approve etc.
The comprehensive details of the proposed change has been described in the URS which is hereby attached.
| N/A | Approved | 30/09/2025 | In Progress | Pharma | 01) Development of Document and data controls system in software. QA
02) Software validation will be performed. Validation
03) SOP for SOP will be revised. QA
04) SOP of Documents and data control will be revised. QA
05) SOP of JD’s will be revised. QA
06) Training of the system will be provided to stakeholders. QA
07) SOP for software of document and data control will be developed. QA
08) Risk assessment will be performed. QA
|
| 1) Dec-25
2) Dec-25
3) Dec-25
4) Dec-25
5) Dec-25
6) Dec-25
7) Dec-25
8) Dec-25
| 14/03/2025 | 04/07/2025 | Hamza Ahmed | Hamza Ahmed |
|
| CMP-0053-25 | 14/03/2025 | Production | Permanent | Major | Shifting of Fette P3030 to cubicle # 03 Compression machines. | Currently, Fette P3030 is installed in Compression cubicle # 1 in Non- Ceph Production. | It is proposed to shift Fette P3030 compression machine from Cubicle # 01 to Cubicle # 03.It is a temporary change due to HVAC upgradation work. After completion of upgradation work, machines will be relocated to their original cubicles. | N/A | Approved | 31/03/2025 | Closed | Pharma | 01) Shifting of Fette P3030 compression machine from Cubicle # 01 to Cubicle # 03 and after working relocation to Cubicle # 01.
02) Qualification of machine.
| All actions have been completed.
1) Done
2) Done
| 1) Mar-25
2) Mar-25-Apr-25
| 14/03/2025 | 21/04/2025 | Hamza Ahmed | Hamza Ahmed |
|
| CMP-0054-25 | 19/03/2025 | SCM | Permanent | Minor | X-Plended Order inst. | Currently X-plended 10mg Tablet is delivered/marketed in local and export market. | First institution order is received from KPT for the product X-plended 10mg 10’s Tablet. A/F text will be printed with green color and U/C are required in green color box. | N/A | Approved | 31/05/2025 | Closed | Pharma | 1) Development and approval of artwork BD
2) Item code will be open for new artwork BD
3)FG code will be opened. SCM
4)BOM will be create in SAP QA
5)BPR will be prepared QA
6)Specifications will be updated. QC
| All actions have been completed.
1) Artwork has been developed.
2) Item code has been opened.
3) Done
4) Done
5) Done
6) Done
| 1) May-25
2) May-25
3) May-25
4) May-25
5) May-25
6) May-25
| 19/03/2025 | 04/07/2025 | Hamza Ahmed | Hamza Ahmed |
|
| CMP-0055-25 | 20/03/2025 | QC | Permanent | Minor | Change in Sample preparation of Ivy Extract in phytus syrup 120ml as per Guatemala query | Currently, in the finished product testing method for Phytus syrup 120ml, the standard preparation of Ivy leaf extract has a concentration of 5mg/ml, while the sample concentration is 4.9mg/ml. | It is proposed to align the sample concentration exactly with the standard concentration, as per the query received from Guatemala, which will require a revision of the finished product testing method. | N/A | Approved | 30/04/2025 | In Progress | Pharma | 1)Finished product testing will be revised.
|
| 1) July-25
| 20/03/2025 | 04/07/2025 | Hamza Ahmed | Hamza Ahmed |
|
| CMP-0056-25 | 21/03/2025 | QC | Temporary | Minor | Malfunctioning of Computer system of FTIR of Non-Ceph QC lab | Currently, all the materials are identified through the FTIR in QC department, which is now malfunctioning which preventing the released of material. | It is proposed that all the materials of Non-Ceph Area will be tested on NIR of Ceph area with the following action plan.
1) Sampling will be performed as per current procedure.
2) After sampling of material QC designee will handover the material to Ceph area QC designee on Ceph area entrance.
3) All the materials will be tested by QC Ceph area analyst and maintain all required logbooks.
4) After testing of the materials, all the results will be shared through mail to Non-Ceph QC lab.
5) QC will print the results and attached with the GRN.
| N/A | Approved | 07/04/2025 | Closed | Pharma | 1) Vendor inspection report is required. QC
2) Evidence of all activities perform is Ceph area will be required. QC
| All actions have been completed.
1) Done
2) Done
| 1) Apr-25
2) Apr-25
| 21/03/2025 | 17/04/2025 | Hamza Ahmed | Hamza Ahmed |
|
| CMP-0057-25 | 21/03/2025 | SCM | Permanent | Major | Additional source induction of Empagliflozin & Dapagliflozin | We have approved source Empagliflozin M.s Jiangsu Yongan, M/s Fuxin Long Rui Pharmaceuticals
Co Ltd & Zhejiang Huayi Pharmaceutical Co.,Ltd.
We have approved source Dapagliflozin M.s Jiangsu Yongan, M/s Fuxin Long Rui Pharmaceuticals
Co Ltd & Zhejiang Huayi Pharmaceutical Co.,Ltd. | We intend to induct one more source for both API's i-e- M/s Zhejiang Huahai Pharmaceutical Co.,Ltd.(Chuannan, Duqio,Linhai, Zhejiang, 317016, China | N/A | Approved | 30/06/2025 | In Progress | Pharma | 01)Variation approval will be required prior to implementation of new source. RA
02)Source approval documents are required. SCM
03)Procurement of material from new source. SCM
04)Vendor list will be updated. QA
05)Source name will be added in LIMS. QC
06)QC will hold the material in SAP after released until the variation approval. QC
07) Process validation will be performed. QA
08) Stability study will be performed. QC
| Source has been approved for Empagliflozin
| Action plan for Empagliflozin:
1) As per need
2) Apr-25
3) Dec-25
4) July-25
5) Dec-25
6) Dec-25(Subjected to procurement
7) Dec-26
8) Dec-26
Action plan for Dapagliflozin:
1) As per need
2) Aug-25
3) Dec-25
4) Aug-25
5) Dec-25
6) Dec-25(Subjected to procurement
7) Dec-26
8) Dec-26
| 21/03/2025 | 05/07/2025 | Hamza Ahmed | Hamza Ahmed |
|
| CMP-0058-25 | 21/03/2025 | Production | Permanent | Minor | To align the header quantity with the actual quantity and align the A/F and CFF quantities | During the finance review variation is found in header quantity and actual quantity of BOM. Secondly variation in quantities of A/F and CFF is observed with respect to actual quantities. | It is proposed to review and align the header and actual quantities of BOM. Secondly to review and standardized the quantities of CFF on the based of higher grammage. | N/A | Approved | 30/06/2026 | In Progress | Pharma | 01) Header quantities of BOM will be align with the actual quantities. QA
02) Production and QA will collect the product list from the finance. Production & QA
03) CFF quantity will be standardized based on the higher grammage and BOM will be revised accordingly. Production & QA
| 1) Done
| 1) Jun-25
2) Jun-26
3) Jun-26
| 21/03/2025 | 04/07/2025 | Hamza Ahmed | Hamza Ahmed |
|
| CMP-0059-25 | 25/03/2025 | PD | Temporary | Major | Final blending of following products will be performed in DCB400Kg in granulation 1 | Following products are manufactured in DCB 400Kg in blending 01 area need to be processed in DCB 400Kg/G1 area.
1. Avsar 80/5mg Tab
2. Avsar 160/10mg Tab
3. Avsar Plus 160/10/12.5mg Tab
4. Lowplat 75mg Tab
5. Lowplat Plus 75mg Tab | Following products will manufactured in DCB 400Kg in G1 area.
1. Avsar 80/5mg Tab
2. Avsar 160/10mg Tab
3. Avsar Plus 160/10/12.5mg Tab
4. Lowplat 75mg Tab
5. Lowplat Plus 75mg Tab
Current Equipment ID:
Blending 01, DCB 400Kg. I.D:E-MP-BLA-01-04-01
Proposed Equipment ID:
G1, DCB 400Kg I.D: E-MP-GRA-01-04-05 | N/A | Approved | 24/03/2025 | Closed | Pharma | 1) Logbook of DCB 400Kg of granulation 1 will be filled for tracebility.
| 1) Done
| 1) Immediate
| 25/03/2025 | 03/06/2025 | Hamza Ahmed | |
|
| CMP-0060-25 | 26/03/2025 | PD | Permanent | Minor | Eliminating the need of potency adjustmenyt in follwing proucts and control through API released potency | Currently potency adjustment is done on API(Metformin) in following products.
1) Erlina Plus XR range
2) Inosita plus range
3) Inosita plus XR range
4) Erli plus XR range
5) Erli plus range
6) Dapwiz plus XR range | It is proposed to eliminate potency adjustment in above mentioned products and instead control the API release potency within the range of 98 % to 102%. | N/A | Approved | 31/05/2025 | In Progress | Pharma | 1) BOM will be revised in SAP. QA
2) BDR and BMR will be revised.QA
3) Routing formula will be update in SAP. Production
4) For interim period BDR will be issued in warehouse by strikethrough the potency calculation pages.
| 1) Done
3) Done
4) Done
| 1) Apr-25
2) May-25
3) Apr-25
4) Apr-25
| 26/03/2025 | 20/04/2025 | Hamza Ahmed | Hamza Ahmed |
|
| CMP-0061-25 | 26/03/2025 | QC | Temporary | Major | Due to malfunctioning of observed in NIR instrument within the QC Ceph lab, all materials test identified by NIR, will be performed as per identification
test by HPLC | Currently, there is a malfunctioning observed in the NIR system within the QC Ceph Lab, which is preventing the release of materials. | It is proposed that all materials in which identification test are required by NIR instrument, test will performed through HPLC identification test. Individual container sample of each API lot will be tested on HPLC instrument. After performing identification test on HPLC, material will be released. | N/A | Approved | 25/03/2025 | In Progress | Pharma | 1) Identification will be done via HPLC. QC
2) Vendor Service report is required. QC
3) Qualification of equipment will be performed. QC/Val
|
| 1) Immediate
2) Aug-25
3) Aug-25
| 26/03/2025 | 04/07/2025 | Hamza Ahmed | Hamza Ahmed |
|
| CMP-0062-25 | 26/03/2025 | QC | Permanent | Major | Update testing method of Ceph Finish products as per current compendia. | Currently, the existing finished products specifications used for the testing of finish Product in Ceph lab was last updated a year ago and remained unchanged. |
It is proposed to revise the testing method of Finish product Specification (List attached) of Ceph Lab as per current pharmacopeial version. | N/A | Approved | 30/09/2025 | In Progress | Pharma | 01) Testing method of the products will be align with current USP method and LIMS specification will be align accordingly. (Products list and existing and proposed USP method attached) QC
02) Revise testing method will be stamped, distributed and archived in QA. QA
03) Previous version of testing method will be obsoleted once new will received. QA
|
| 1) Sep-25
2) Sep-25
3) Sep-25
| 26/03/2025 | 20/04/2025 | Hamza Ahmed | Hamza Ahmed |
|
| CMP-0063-25 | 26/03/2025 | QC | Permanent | Major | Transition of QC sample receiving procedure from Manual entries of Samples received in Log Book to Online sample receiving system via SAP software | Currently, QC manually records the samples received from QA in the sampling receipt log book. | It is proposed that All sample reconciliation will be maintained in SAP. SAP process flow will be defined as below: Current Process Posting of Bulk from Production in SAP Generation of sampling intimation form . Sampling intimation form manually filled by QA . Sample quantity is mentioned and submitted to QA QC maintained the Batch Receiving and sample Qty data manually in logbook QC perform the UD on bulk and complete Quantity posted for further process Additional samples maintain manually Proposed process Posting of Bulk from Production in SAP Generation of sampling intimation form . Sampling intimation form to be filled by QA in SAP. Sample quantity to be automatically deduct from the bulk posting. QC perform the UD on bulk, sample quantity appear in samples and rejected Qty to be posted in scrap. Tablet consume in testing also required Remaining Quantity posted for further process Reconciliation of sample quantity to be available in form of report which display the total sample quantity, Consume Quantity and the quantity rejected during testing. Further in case of any additional sampling requirement ,it also need to be added in that particular batch | N/A | Approved | 30/09/2025 | In Progress | Pharma | 1) Changes will be made in SAP through IT. QC
2) PQ of the change will be performed. Validation
3) SOP for “raw material, semi-finished and finished
Product analysis” QCG/2/023 will be revised. QC
4) SOP for “sampling of intermediate and finished products "will be revised. QA
5)Training will be provided to concern stakeholers. QC
|
| 1) Sep-25
2) Oct-25
3) Oct-25
4) Oct-25
5) Oct-25
| 26/03/2025 | 04/07/2025 | Hamza Ahmed | Hamza Ahmed |
|
| CMP-0064-25 | 28/03/2025 | SCM | Permanent | Major | Induction of new API locasonide | Currently API locasonide is not approved in Pharmevo facility. | It is proposed to induct and approved API locasonide in pharmevo facility. | N/A | Approved | 31/12/2026 | In Progress | Pharma | 01) PD trial documents and stability will be submitted PD
02) Source approval documents will be submitted to QA. SCM
03) Procurement of material form new source. SCM
04) Vendor list will be update. QA
05) Source name will be added in LIMS. QC
06) Process validation will be performed. QA
07) Stability will be performed on validation batches. QC
08) QC will hold the lot in SAP after released. QC
|
| 1) Nov-25
2) Apr-25
3) May-25
4) May-25
5) May-25
6) Dec-26
7) Dec-26
8) May-25
| 28/03/2025 | 14/05/2025 | Hamza Ahmed | Hamza Ahmed |
|
| CMP-0065-25 | 07/04/2025 | BD | Permanent | Minor | Launch 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/A | Approved | 30/06/2025 | In Progress | Pharma | 01) Product launch in Cambodia.
BD
02) Development and approval of artwork. BD
03) Item code of packaging materials will be opened. BD
04) FG codes will be opened.
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 developed in LIMS. QC
| Actions mentioned below are completed for all products:
2) Artworks have been developed.
3) Done
4) FG codes have been opened.
| Timelines for sacvin 200mg Tab:
1) Jun-25 (Extended till Nov-25)
2) Apr-25
3) Apr-25
4) May-25
5) Jun-25 (Extended till Nov-25)
6) Jun-25 (Extended till Nov-25)
7) Jun-25 (Extended till Oct-25)
8) Jun-25 (Extended till Nov-25)
Timelines for all products mentioned in the list:
1) Jun-25 (Extended till Nov-25)
2) May-25
3) May-25
4) May-25
5) Jun-25 (Extended till Nov-25)
6) Jun-25 (Extended till Nov-25)
7) Jun-25 (Extended till Oct-25)
8) Jun-25 (Extended till Nov-25)
| 07/04/2025 | 05/07/2025 | | Hamza Ahmed |
|
| CMP-0066-25 | 08/04/2025 | QC | Temporary | Minor | Weight specification of Glass vial | Currently, glass vials are received from the ACL having weight specifications is 24 ± 1 gm. | Recently Glass Vials lot no 0000058705 received from ACL having weight specification 23 ± 1 gm which is not comply with the Standard specification limit of weight variation. Although very slight change in weight is observed therefore it is proposed to consume only this lot 0000058705. | N/A | Approved | 30/04/2025 | Closed | Pharma | 1) QC will released the lot.
| 1) Action has been closed.
| 1) Closed
| 14/04/2025 | 04/07/2025 | Hamza Ahmed | Hamza Ahmed |
|
| CMP-0067-25 | 08/04/2025 | SCM | Permanent | Major | Additional source induction of Ticagrelor | We have approved sources for ticagrelor as M/s Jiangxi Synergy, CTX life sciences & Nantong Chanyoo Pharmatech Co, Ltd. | We intend to induct one more source M/s Gansu Haotian Pharmatech Co, Ltd. Address No. 11 Chongqing Road, Baiyin district, Baiyin City, Gansu Province, Chine. | N/A | Approved | 30/07/2026 | In Progress | Pharma | 01) Source approval documents will be submitted to QA. SCM
02) Procurement of material form new source. SCM
03) Vendor list will be update. QA
04) Source name will be added in LIMS. QC
05) Process validation will be performed. QA
06) Stability will be performed on validation batches. QC
07) Variation will be applied for new source. RA
8) QC will hold the lot after released. QC
| 1) Source has been approved.
| 1) May-25
2) Dec-25
3) June-25
4) Dec-25
5) July-26
6) July-26
7) Dec-26
8) Dec-25
| 16/04/2025 | 04/07/2025 | Hamza Ahmed | Hamza Ahmed |
|
| CMP-0068-25 | 24/04/2025 | SCM | Permanent | Minor | Change in Manufacturer name of Emerald Kalama Chemical. | We have approved Manufacturer by the name of Emerald Kalama Chemical.The manufacturer is approved for the following Material, Sodium Benzoate.
Address: Fascinatio Boulevard 230 3065 WB Rotterdam, The Netherlands.
| It is to proposed that Manufacturer name has been changed to Lanxess Chemical B.V. from Emerald Kalama Chemical while the Manufacture site/material will remain same.
Address: Fascinatio Boulevard 230 3065 WB Rotterdam, The Netherlands.
| N/A | Approved | 31/05/2025 | Closed | Pharma | 1) Administrative document is required. SCM
2) Vendor List will be updated.
3) Manufacturer name will be updated in LIMS. QC
| All actions have been completed.
| 1) Done
2) Apr-25
3) May-25
| 24/04/2025 | 04/07/2025 | Hamza Ahmed | Hamza Ahmed |
|
| CMP-0069-25 | 24/04/2025 | SCM | Temporary | Minor | Usage of API Linagliptin lot number 2024110501 with particle size 188 micorn | QC has rejected the material Linagliptin lot number 2024110501 because out of specification result was observed in particly size.
Actual Prticle Size D(90) : 15micron Observed Prticle Size D(90) : 188micron
| It is proposed to used the API Linigliptin lot number 2024110501 with particle size 188micron
| N/A | Approved | 31/08/2025 | In Progress | Pharma | 01) GRN will be create in SAP. WH
02) QC will released the material and immediately hold the material till the satisfactory results of PD trial. QC
03) Trial will be performed on Erlina plus XR Tablet at both Tablet and API coating. PD
04) After satisfactory results material will be unhold by QC for issuance of material in manufacturing of commercial batch. QC
| 1) GRN has been created.
2) Done
| 1) May-25
2) May-25
3) Aug-25
4) Aug-25
| 24/04/2025 | 05/07/2025 | Hamza Ahmed | |
|
| CMP-0070-25 | 29/04/2025 | BD | Permanent | Minor | Launch of Reestatin tablet 10mg (10*10's) in Philippines | The product is launched in Philippines yet. | The product Reestatin(Rosuvastatin) tablet 10mg (10*10's) is planned to launch in Philippines. | N/A | Approved | 31/08/2025 | In Progress | Pharma | 1) EX registration is required prior to implementation. RA
2) Product launch in Philippines. BD
3) Development and approval of artwork. BD
4) Item code of packaging materials will be opened. BD
5) FG codes will be opened.
SCM
6) BOM will be create in SAP. QA
7) BPR will be prepared. QA
8) Procurement of packaging material. SCM
9) Specification will be developed in LIMS. QC
| 1) Done
3) Artwork has been developed.
4) Done
5) FG code has been opened.
| 1) Jun-25
2) Aug-25
3) Done
4) Done
5) Jun-25
6) Aug-25
7) Aug-25
8) July-25
9) Aug-25
| 29/04/2025 | 04/07/2025 | Hamza Ahmed | Hamza Ahmed |
|
| CMP-0071-25 | 29/04/2025 | SCM | Permanent | Minor | Use of Generic Name of Excipient “Hypromellose 4000SR” | Currently we are Procuring Hypromellose 4000SR with the brand name of Tylopur 90Sh 4000SR and HPMC K4M. However in SAP this excipient is mentioned with the name of HPMC K4M with material Code No. 1100000369. | It is proposed to use single generic name i.e. Hypromellose 4000SR. with material Code No. 1100000369 | N/A | Approved | 31/07/2025 | In Progress | Pharma | 01) Old code will be blocked.
SCM
02) New code will be opened and inventory will be transfer to new code. SCM
|
| 1) July-25
2) July-25
| 29/04/2025 | 04/07/2025 | Hamza Ahmed | Hamza Ahmed |
|
| CMP-0072-25 | 29/04/2025 | SCM | Permanent | Minor | Additional source induction of Omeprazole Pellets 12.5% | We have approved source of Omeprazole Pellets 12.5% M/s. Cohance Lifescience | We intend to induct one more source M/s. Vision Pharmaceuticals (Pvt) Ltd.
Address: PLOT NO: 22-23, INDUSTRIAL TRIANGLE KAHUTA ROAD, ISLAMABAD
| N/A | Approved | 31/03/2026 | In Progress | Pharma | 01) Source approval documents will be submitted to QA. SCM
02) Procurement of material form new source. SCM
03) Vendor list will be update. QA
04) Source name will be added in LIMS. QC
05) Drap approval is required prior to implementation. RA
06) QC will hold the lot in SAP after released. QC
07) Process validation will be performed. QA
08) Stability will be performed on valiadation batches. QC
| 1) Done
| 1) May-25
2) Aug-25
3) Aug-25
4) Aug-25
5) Sep-25
6) Aug-25
7) Mar-26
8) Mar-26
| 29/04/2025 | 04/07/2025 | Hamza Ahmed | Hamza Ahmed |
|
| CMP-0073-25 | 30/04/2025 | Production | Permanent | Minor | Pre Nitrogen purging during suspension filling in HHFZ suspension filling machine (Ceph Production). | Currently, during suspension filling pre nitrogen purging is performed on HHFZ suspension filling machine installed in Ceph Production. | It is proposed to induct post nitrogen purging during suspension filling on HHFZ suspension filling machine installed in Ceph Production. | N/A | Approved | 31/07/2025 | In Progress | Pharma | 01) Nitrogen purging system will be installed in HHFZ suspension filling machine Engg
02) Switch will be provided in machine, as the continuous nitrogen supply stops in the sachet machine, the machine will also automatically stop. Engg
03) Continuous nitrogen purging will be verified and qualified. Validation
| 1) Done
2) Done
| 1) May-25
2) May-25
3) July-25
| 30/04/2025 | 04/07/2025 | Hamza Ahmed | Hamza Ahmed |
|
| CMP-0074-25 | 30/04/2025 | SCM | Permanent | Minor | Additional source induction of Lactose Monohydrate 200mesh | We are currently procuring Excipient: Lactose Monohydrate 200mesh from M/s. DFE Pharma GmbH & Co, Ltd | We intend to induct one more source M/s. KERRY-LEPRINO FOODS CO., TRACY, CA
Add: Americas Region, 3400 Millington Road, Beloit, WI 53511, 1.608.363.1200, USA
| N/A | Approved | 30/09/2025 | In Progress | Pharma | 01) Source approval documents will be submitted to QA. SCM
02) Procurement of material form new source. SCM
03) Vendor list will be update. QA
04) Source name will be added in LIMS. QC
| 1) Source has been approved.
| 1) Jun-25
2) Sep-25
3) Aug-25
4) Aug-25
| 30/04/2025 | 04/07/2025 | Hamza Ahmed | Hamza Ahmed |
|
| CMP-0075-25 | 30/04/2025 | SCM | Permanent | Major | Additional source induction of Clopidogrel bisulphate | We have approved sources for Clopidogrel bisulphate as M/s AARTI DRUGS, SYNTHIMED LABS PVT LTD & CADCHEM LABORATORIES. | We intend to induct one more source M/s. Huizhou Salubris Pharmaceutical Co., Ltd.
Address: No.42 West Petrochemical Avenue Daya Bay Economic and Technological Development Zone, Huizhou, Guangdong, China
| N/A | Approved | 31/01/2026 | In Progress | Pharma | 01) Source approval documents will be submitted to QA. SCM
02) Procurement of material form new source. SCM
03) Vendor list will be update. QA
04) Source name will be added in LIMS. QC
05) Variation approval is required prior to implementation. RA
06) QC will hold the lot in SAP after released. QC
07) Process validation will be performed. QA
08) Stability will be performed on validation batches. QC
| 1) Source has been approved.
| 1) June-25
2 )Aug-25
3) Aug-25
4) Sep-25
5) Jan-26
6) Sep-25
7) Dec-25
8) Dec-25
| 30/04/2025 | 04/07/2025 | Hamza Ahmed | Hamza Ahmed |
|
| CMP-0076-25 | 07/05/2025 | PD | Permanent | Major | New launch product vibegron 75mg Tablet | Product and development activities of generic vibegron 75mg Tablet has been completed. | It is proposed to commercialize vibegron 75mg Tablet in Pharmevo facility. | RA-0017-25 | Approved | 31/10/2026 | In Progress | Pharma | 01) Trail documents are required.
PD
02) Stability study documents are required. PD
03) Containment Approach and cleanability report is required. PD
04) Technology transfer protocol (for process) is required. PD
05) Technology transfer protocol (for analytical testing) is required. PD
06) Regulatory approval required before commercialization. RA
07) Source approval documents is required. SCM
08) Procurement of required raw materials i.e. vibegron. SCM
09) Artwork will be developed and approved. BD
10) Specification of packaging material will be developed QC
11) Item codes will be opened for new developed artwork. SCM
12) FG code will be opened. SCM
13) Procurement of packaging material. SCM
14\) Analytical testing method will prepare and update on LIMS. QC
15) BOM will be create in SAP. QA
16) Batch documents (BDR, BMR, BYS, BPR) will be prepared. QA
17) Routing will be created in SAP. Production
18) Planning of product launch for commercial. BD
19) Process validation will be performed. QA(Val)
20) Product will be charge on stability. QC
| 1) Done
2) Done
6) Done
7) Done
| 1) Done
2) Done
3) Jun-25(Extension till Aug-25)
4) Jun-25(Extension till Oct-25)
5) Jun-25(Extension till Oct-25)
6) Done
7) Done
8) Sep-25
9) July-25
10) Oct-25
11) July-25
12) July-25
13) Sep-25
14) Oct-25
15) Sep-25
16) Sep-25
17) Sep-25
18) Sep-25
19) May-26
20) Oct-26
| 07/05/2025 | 04/07/2025 | Hamza Ahmed | Hamza Ahmed |
|
| CMP-0077-25 | 07/05/2025 | QA | Permanent | Minor | To hormonize the title of manufacturing facilities in all documents at PharmEvo Site, namely Cephalosporin , General Pharma (Non-Cephalosporin) and Nutraceutical | At PharmEvo factory site there are three manufacturing facilities namely Cephalosporin, Non-Cephalosporin and Nutraceuticals. Each manufacturing facilitiy has its dedicated equiment, personal, HVAC systems and other requirements. All the documentation prepared at the site contains the similar titles of these areas. | Keeping in view of the above it is proposed that the nomenclature “Non-Cephalosporin” should be replaced with “General Pharma (Non-Ceph)” in all the GMP documentation for being more appropriate title to indicate the manufacturing area. This will be applicable to all the documentation throughout the PharmEvo factory site.
This change will be implemented immediately however it will come in force in the individual document at the time of its review date.
| N/A | Approved | 31/07/2025 | In Progress | Pharma | 01) Site master file will be revised. QA
02) Quality Manual will be revised. QA
03) Formal communication will be share to all stakeholders. QA
| 01) Done
| 01) June-25
02) July-25
03) July-25
| 07/05/2025 | 05/07/2025 | Hamza Ahmed | Hamza Ahmed |
|
| CMP-0078-25 | 07/05/2025 | SCM | Permanent | Minor | Additional source induction of Gelatine Powder 150LB | We are currently procuring Excipient: Gelatine Powder 150LB from M/s. ROUSSELOT (DA'AN) GELATIN CO., LTD, CHINA | We intend to induct one more source M/s. GELCAPS PAKISTAN LIMITED
Add: PLOT B-43 HUB INDUSTRIAL TRADING, ESTATE DISTRICTLASBELLA BALOCHISTAN, PAKISTAN.
| N/A | Approved | 30/06/2026 | In Progress | Pharma | 01) Source approval documents will be submitted to QA. SCM
02) Procurement of material form new source. SCM
03) Vendor list will be update. QA
04) Source name will be added in LIMS. QC
|
| 1) July-25
2) Jun-26
3) Oct-25
4) July-25
| 07/05/2025 | 02/07/2025 | Hamza Ahmed | Hamza Ahmed |
|
| CMP-0079-25 | 07/05/2025 | SCM | Permanent | Major | Additional source induction FEBUXOSTAT | We are currently procuring Excipient: FEBUXOSTAT from ENALTEC LABS PVT.LTD, INDIA, METROCHEM API PRIVATE LIMITED, INDIA & PRUDENCE PHARMA CHEM, INDIA | We intend to induct one more source M/s. ZHEJIANG HUAYI PHARMACEUTICAL CO., LTD
Add: NO.15 SHUANGFENG RD., FOTANG, YIWU, ZHEJIANG 322002, CHINA
| N/A | Approved | 31/07/2026 | In Progress | Pharma | 01) Source approval documents will be submitted to QA. SCM
02) Procurement of material form new source. SCM
03) Vendor list will be update. QA
04) Source name will be added in LIMS. QC
05) Variation approval is required prior to implementation. RA
06) QC will hold the lot in SAP after released. QC
07) Process validation will be performed. QA
08) Stability will be performed on validation batches. QC
| 1) Source has been approved.
| 1) Jun-25
2) Aug-25
3 July-25
4) Sep-25
5) Nov-25
6) Sep-25
7) July-26
8) July-26
| 07/05/2025 | 04/07/2025 | Hamza Ahmed | Hamza Ahmed |
|
| CMP-0080-25 | 07/05/2025 | Enginnering | Permanent | Minor | Shifting of manual Maintenance recording system to SAP generated Maintenance recording system | Currently, as per SOP No. ENO/2/065, Maintenance Technicians record maintenance activities manually in hard copy logbooks (ENG/5/014) located near each machine. Afterward, they verbally communicate the details to the Maintenance Officer or designee.
The Maintenance Officer then re-enters the same information into the SAP PM Module and confirms the order.
| It is proposed to eliminate the manual entry of maintenance activities in the hard copy logbooks (ENG/5/014). Instead, Maintenance Technicians will directly communicate all maintenance activities to the concerned Maintenance Personnel, who will then enter the details into the SAP PM Module at the time of activity completion.
Subsequently, the Maintenance Order Report can be viewed through T-Code ZMO, ensuring accurate and timely documentation within a single system.
| N/A | Approved | 31/08/2025 | In Progress | Pharma | 1) SOP of breakdown will be revised. Engg
2) SAP ID is required for maintenance officer. Engg
|
| 1) Aug-25
2 )Aug-25
| 07/05/2025 | 04/07/2025 | Hamza Ahmed | Hamza Ahmed |
|
| CMP-0081-25 | 07/05/2025 | SCM | Permanent | Major | Additional source induction of BISOPROLOL FUMARATE | We are currently procuring API: BISOPROLOL FUMARATE from M/S. MEHTA API PVT LTD & M/S. SMART PHARMACEUTICALS- INDIA. | We intend to induct one more source M/s. Sichuan Qingmu Pharmaceutical Co. Ltd.
Add: No. 55, South Shunjiang Avenue, East Economic Development Zone, Dongpo District, Meishan City, Sichuan Province, China.
| N/A | Approved | 31/08/2025 | In Progress | Pharma | 01) Source approval documents will be submitted to QA. SCM
02) Procurement of material form new source. SCM
03) Vendor list will be update. QA
04) Source name will be added in LIMS. QC
05) Variation approval is required prior to implementation. RA
06) QC will hold the lot in SAP after released. QC
07) Process validation will be performed. QA
08) Stability will be performed on validation batches. QC
|
| 1) July-25
2) Aug-25
3) Aug-25
4) Aug-25
5) Mar-25
6) Aug-25
7) Aug-26
8) Aug-26
| 07/05/2025 | 03/07/2025 | Hamza Ahmed | Hamza Ahmed |
|
| CMP-0082-25 | 07/05/2025 | BD | Permanent | Minor | Launch of New Products in Uzbekistan. | The products mentioned in table is not launched in Uzbekistan yet.
S.No 01
Product Erli 25mg
Generic Empagliflozin
Pack Size 2x7's
Shelf Life 24 months
Registration Timeline Registered
Pack size in Local 14's
(For reference only)
| This product is planned for launch in Uzbekistan. | N/A | Approved | 31/08/2025 | In Progress | Pharma | 01) Planning of product launch for commercial. BD
02) Development of artwork. BD
03) Item code will be opened. BD
04) FG code will be opened. 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 developed in LIMS. QC
| 2) Artwork has been developed.
3) Item code has been opened.
4) FG code has been developed.
| 1) Aug-25
2) Jun-25
3) Jun-25
4) Jun-25
5) Aug-25
6) Aug-25
7) Aug-25
8) Aug-25
| 07/05/2025 | 04/07/2025 | Hamza Ahmed | Hamza Ahmed |
|
| CMP-0083-25 | 07/05/2025 | QC | Permanent | Minor | Change in formulation of Dapwiz Plus XR 5/1000mg and 10/1000mg Tablet | During the compression stage, layer separation was observed in the following strengths of Dapwiz
Plus XR. This issue appears to be due to a weight difference between the two layers.
The target weight of the
Dapagliflozin layer is 300mg per tablet.
Product Name:
Dapwiz plus 5/1000mg
Material: Quantity
Dapagliflozin 6.130Kg
MCC-102 213.600Kg
Product Name:
Dapwiz plus 10/1000mg
Material: Quantity
Dapagliflozin 12.300Kg
MCC-102 207.450Kg
| It is proposed that target weight Dapagliflozin layer will be increased to 400mg/tab by increasing the quantity of diluent
Product Name:
Dapwiz plus 5/1000mg
Material: Quantity
Dapagliflozin 6.130Kg
MCC-102 313.600Kg
Product Name:
Dapwiz plus 10/1000mg
Material: Quantity
Dapagliflozin 12.300Kg
MCC-102 307.450Kg | RA-0018-25 | Approved | | In Progress | Pharma | Actions plans are same for both strengths:
01) PD trial is required. PD
02) Variation will be applied upon availability of technical documents. RA
03) SFG BOM will be revised. QA
04) BDR and BMR will be revised. QA
05) Routing will be created in SAP. Production.
06) Process validation will be performed. Validation
07) Testing method will be revised. QC
08) LIMS specs will be revised. QC
09) Stability will be performed. QC
| 3) SFG BOM for Dapwiz Plus XR 10/1000mg has been revised.
4) BDR and BOM for Dapwiz Plus XR 10/1000mg has been revised.
5) Routing has been created for Dapwiz Plus XR 10/1000mg has been revised.
7) Done for Dapwiz Plus XR 10/1000mg has been revised.
8) Done for Dapwiz Plus XR 10/1000mg has been revised.
| Timelines for Dapwiz Plus XR 5/1000mg Tab:
1) Done
2)
3) Aug-25
4) Aug-25
5) Aug-25
6) Feb-26
7) July-25
8) July-25
9) Feb-26
Timelines for Dapwiz Plus XR 10/1000mg Tab:
1) Done
2)
3) May-25
4) May-25
5) May-25
6) Feb-26
7) May-25
8) May-25
9) Feb-26
| 07/05/2025 | 04/07/2025 | Hamza Ahmed | Hamza Ahmed |
|
| CMP-0084-25 | 07/05/2025 | SCM | Permanent | Minor | Additional source induction of AMMONIUM GLYCCYRHIZINATE | We are currently procuring Excipient: AMMONIUM GLYCCYRHIZINATE from M/s. VITAL CHEM, CHINA | We intend to induct one more source M/s. SINOPHARM XINJIANG JINXING LICORICE PRODUCTS CO.,LTD.
Add: NO. 148 TAI CHANG ROAD, KORLE ECONOMIC AND TECHNICAL DEVELOPMENT
ZONE,XINJIANG,CHINA
| N/A | Approved | 31/08/2025 | In Progress | Pharma | 01) Source approval documents will be submitted to QA. SCM
02) Procurement of material form new source. SCM
03) Vendor list will be update. QA
04) Source name will be added in LIMS. QC
|
| 1) Done
2) Aug-25
3) Aug-25
4) Sep-25
| 08/05/2025 | 03/07/2025 | Hamza Ahmed | Hamza Ahmed |
|
| CMP-0085-25 | 13/05/2025 | QC | Permanent | Minor | Revision of specification of Tamsulosin 0.4mg capsule from USP Dissolution Test I to USP Dissolution test II | Currently dissolution of Tamsulosin 0.4mg capsules tested as per USP Dissolution Test I parameters | It is proposed to revise the dissolution of Tamsulosin 0.4mg capsules tested as per USP Dissolution Test II parameters. | N/A | Approved | 30/06/2025 | Closed | Pharma | 01) Analytical testing method will be revised. QC
02) Method verification will be performed. QC
03) Variation will be submitted in Kenya. RA
| 1) Analytical testing method has been revised.
2) Done
3) Variation has been submitted in kenya.
| 1) June-25
2) June-25
3) June-25
| 13/05/2025 | 05/07/2025 | Hamza Ahmed | Hamza Ahmed |
|
| CMP-0086-25 | 15/05/2025 | Production | Permanent | Major | Increases in Batch sizes of products | Currently, the following products are available in different batch sizes, but they are not sufficient to meet market demand. | It is proposed to increase the batch sizes of products mentioned below:
1. Erlina Plus XR 5/2.5.1000mg
2. Erlina Plus XR 10/5/1000mg
3. Erlina Plus XR 12.5/2.5/1000mg
4. Erlina Plus XR 25/5/1000mg
5. Ramipace 10mg Tablet
List of products with batch size and equipment details is attached.
| N/A | Approved | 31/01/2026 | In Progress | Pharma | 01) SFG and FG BOM will be revised in SAP QA
02) BDR, BMR and BPR will be revised QA
03) Process validation will be performed QA(Val)
04) Product will be charged on stability QC
05) Variation will be submitted in export. RA
|
| 1) Oct-25
2) Oct-25
3) Dec-25
4) Dec-25
5) June-26
| 15/05/2025 | 05/07/2025 | Hamza Ahmed | Hamza Ahmed |
|
| CMP-0087-25 | 15/05/2025 | PD | Permanent | Minor | Change in coating material of Xcept 2.5mg, 10mg, 15mg and 20mg Tablet. | Currently, Sheffcoat PVA White (5Y01440) is being used as the coating material for the Xcept Tablet range. This material was originally introduced as an alternate source in place of Opadry White II (85G68918). | It is proposed to replace Sheffcoat PVA White (5Y01440) with Opadry White II (85G68918) as the coating material in the Xcept Tablet range. | N/A | Approved | 30/09/2025 | In Progress | Pharma | 01) SFG BOM will be revised in SAP. QA
02) BDR, BMR will be revised. QA
|
| 1) Sep-25
2) Sep-25
| 15/05/2025 | 05/07/2025 | Hamza Ahmed | Hamza Ahmed |
|
| CMP-0088-25 | 15/05/2025 | Production | Permanent | Minor | Inclusion of primary packaging material (Aluminum foil) in manufacturing order for Sachet Products (Non-Ceph). | Currently, the primary packaging materials (Aluminum foil) for sachet products are part of the Packaging Order process. Aluminum foil is issued after the completion of the manufacturing process. | We propose to include the primary packaging materials (Aluminum foil) in Manufacturing Order, aligning the Aluminum foil issuance with the dispensing of raw materials. Dispensing procedure will remain same for raw and packaging material.
1. Actiflor 250mg Sachet
2. Onita 2gm Sachet
3. Aireez 4mg Sachet | N/A | not Approved | | Closed | Pharma |
| During impact assessment it came to know that it is not possible to implement this change because of different orders in single batch. Therefore, this change is closed without implementation.
|
| 15/05/2025 | 05/07/2025 | Hamza Ahmed | Hamza Ahmed |
|
| CMP-0089-25 | 15/05/2025 | SCM | Permanent | Major | Additional source induction HYDROCHLOROTHIAZIDE | We are currently procuring API : HYDROCHLOROTHIAZIDE from CHANGZHOU PHARMACEUTICAL FACTORY, CHINA & M/s. CTX LIFESCEINCES PVT. LTD., INDIA
| We intend to induct one more source M/s. SUZHOU LIXIN PHARMACEUTICAL CO LTD
Add: NO.21 TANGXI ROAD, SUZHOU NEW DISTRICT, SUZHOU, JIANGSU PROVINCE 215151, P.R. OF CHINA
| N/A | Approved | 31/07/2026 | In Progress | Pharma | 01) Source approval document will be submitted to QA SCM
02) Procurement of material from new source SCM
03) Vendor list will be updated QA
04) Source name will be added in LIMS QC
05) Process validation will be performed. QA
06) Stability will be performed on validation batches. QC
7) Variation approval is required prior to implementation. RA
8) QC will hold the material after released till variation approval.
| 1) Source has been approved.
| 1) May-25
2) July-25
3) July-25
4) July-25
5) July-26
7) July-26
7) Dec-25
8) July-25
| 15/05/2025 | 05/07/2025 | Hamza Ahmed | Hamza Ahmed |
|
| CMP-0090-25 | 16/05/2025 | Production | Permanent | Minor | Includion of primary packaging material (Bottle Caps and Labels) in Manufacturing Orders for Suspension Products (Ceph Area). | Currently, the primary packaging materials (bottle caps and labels) for suspension products are part of the Packaging Order process. Bottle,caps and labels is issued after the completion of the manufacturing process. | We propose to include the primary packaging materials (bottle caps and labels) into the Manufacturing Order, aligning the bottle, caps and labels issuance with the dispensing of raw materials. Dispensing procedure will remain same for raw and packaging material.(List of suspension product is attached) | N/A | Approved | 31/10/2025 | In Progress | Pharma | 01) SFG and FG BOM will be revised in SAP. QA
02) BDR will be revised. QA
|
| 1) Oct-25
2) Oct-25
| 16/05/2025 | 05/07/2025 | Hamza Ahmed | Hamza Ahmed |
|
| CMP-0091-25 | 16/05/2025 | PD | Permanent | Major | Change in formulation of Inosita 25mg, 50mg and 100mg tablet | Currently, Inosita 25mg, 50mg and 100mg tablet is being manufacture red as per formulation attached in annexure I. | It is proposed to change the quantity of magnesium stearate to 2.5mg/Tab, 4mg/ tab and 4.5mg/Tab in Inosita 25mg, 50mg and 100mg tablet respectively as mentioned in the formulation attached in annexure I. | RA-0021-25 | Approved | 28/02/2026 | In Progress | Pharma | 01) PD trial and stability is required. PD
02) Regulatory approval is required RA
03) SFG BOM will be revised in SAP. QA
04) BDR and BMR will be revised. QA
05) Process validation will be performed. QA (Val)
06) Stability study will be performed. QC
7) Stability studies will be performed.
| 1) Trial and stability have been submitted.
| 1) Aug-25
2) Feb-26
3) Sep-25
4) Sep-25
5) Sep-25
6) Dec-25
7) Dec-25
| 16/05/2025 | 05/07/2025 | | Hamza Ahmed |
|
| CMP-0092-25 | 23/05/2025 | BD | Permanent | Minor | Launch of Additional Pack Size of Product in Tajikistan. | The below mentioned product is already launched in the mentioned pack size in Tajikistan. S.No : 01 Product: Emglin(Erli) 10mg Tablet: Generic: Empagliflozin 10mg Pack Size : 2x7's Shelf Life : 24 Months Registration Timeline : Registered | It is proposed to Launch below product in mentioned pack size in Tajikistan. S.No : 01 Product: Emglin(Erli) 10mg Tablet: Generic: Empagliflozin 10mg Pack Size : 4x7's Shelf Life : 24 Months Registration Timeline : Registered | N/A | Approved | 31/08/2025 | In Progress | Pharma | 01) Launch of additional pack size in Tajikistan . BD 02) Artwork will be developed. BD 03) Item code will be opened against new developed artwork. BD 04) FG code will be opened. SCM 05) FG BOM will be prepared in SAP. QA 06) BPR will be prepared. QA 07) LIMS specification will be updated. QC 08) Procurement of packaging material. SCM
|
| 1) Aug-25
2) July-25
3) July-25
4) July-25
5) Aug-25
6) Aug-25
7) July-25
8) Aug-25
| 24/05/2025 | 04/07/2025 | Hamza Ahmed | Hamza Ahmed |
|
| CMP-0093-25 | 23/05/2025 | QC | Permanent | Minor | Change in specification of raw material Ibandronate Sodium from in-house specification to USP – 43.
| Currently, the specifications for the API raw material (Ibandronate Sodium) from the manufacturers—Fleming Laboratories Limited and JPN Pharma Private Limited—are based on in-house claims. | It is proposed to revise the specification of Ibandronate Sodium from in-house specification to
USP – 43.
| N/A | Approved | 31/12/2025 | In Progress | Pharma | 01) Specification agreement as per USP will be submitted to SCM. QC
02) Updated specification agreement will be arranged from all vendors. SCM
03) Testing method will be revised as per USP specs. QC
04) Standards and supply columns will be arranged. QC
05) API verification will be performed. QC
06) Standardization will be performed. QC
07) Artwork will be revised to update the specs. BD
08) Item code will be opened for revised artwork. BD
09) BOM will be revised. QA
|
| 1) Done
2) Done
3) Dec-25
4) Oct-25
5) Dec-25
6) Oct-25
7) Aug-25
8) Aug-25
9) Dec-25
| 24/05/2025 | 05/07/2025 | Hamza Ahmed | Hamza Ahmed |
|
| CMP-0094-25 | 23/05/2025 | QC | Permanent | Minor | Change in specification of raw material Sumatriptan Succinate from in-house specification to BP. | Currently, the specifications for the API raw material (Sumatriptan Succinate) from the manufacturers—Hunan Jiudian Hongyang—are based on in-house claims. | It is proposed to revise the specification of Sumatriptan Succinate from in-house specification to
BP.
| N/A | Approved | 31/12/2025 | In Progress | Pharma | 01) Specification agreement as per BP will be submitted to SCM. QC
02) Updated specification agreement will be arranged from all vendors. SCM
03) Testing method will be revised as per USP specs. QC
04) Standards and supply columns will be arranged. QC
05) API verification will be performed. QC
06) Standardization will be performed. QC
07) Artwork will be revised to update the specs. BD
08) Item code will be opened for revised artwork. BD
09) BOM will be revised. QA
|
| 1) Done
2) Done
3) Dec-25
4) Oct-25
5) Dec-25
6) Dec-25
7) Aug-25
8) Aug-25
9) Dec-25
| 24/05/2025 | 05/07/2025 | Hamza Ahmed | Hamza Ahmed |
|
| CMP-0095-25 | 27/05/2025 | QC | Temporary | Minor | Particle size of Clopidogrel Bisulphate Lot No. 59314 from Synthimed Labs Pvt. Ltd. is less than the specification at 148 µm, below the acceptable limit of 200-600 µm. | At present, the particle size results for the API raw material "Clopidogrel Bisulphate" Lot No.
59314 from the manufacturer" Synthimed Labs Private Limited" have been identified as less than
the specification, measuring at (148 m), whereas the acceptable limit is 200 -600 micron. | It is proposed to allow the release of Clopidogrel Bisulphate, Lot No. 59314.
Product and development (PD) will manufacture a trial batch. Upon obtaining satisfactory results
from the trial batch, one commercial batch will be manufactured using Clopidogrel Bisulphate Lot
No. 59314. Extensive testing will be performed by QC on the commercial batch, and upon
satisfactory results, the lot will be released. | N/A | Approved | 31/08/2025 | In Progress | Pharma | 01) GRN will be create in SAP. WH
02) QC will released the material and immediately hold the material till the satisfactory results of PD trial. QC
03) Trial will be performed on Erlina plus XR Tablet at both Tablet and API coating. PD
04) After satisfactory results material will be unhold by QC for issuance of material in manufacturing of commercial batch. QC
| 1) GRN has been created.
2) Done
| 1) June-25
2) June-25
3) Aug-25
4) Aug-25
| 27/05/2025 | 05/07/2025 | Hamza Ahmed | Hamza Ahmed |
|
| CMP-0096-25 | 27/05/2025 | BD | Permanent | Minor | Launch of Rosuvastatin Tablets 10mg (10x10’s) in Philippines. | This product is not launched in Philippines yet. | The product Rosuvastatin Tablets 10mg (10x10’s) is planned for launch in Philippines. | N/A | Approved | 31/08/2025 | In Progress | Pharma | 01) Planning of product launch for commercial. BD 02) Development and approval artwork (U/C, A/F and D/I). BD 03) Item code will be opened. BD 04) FG code will be opened. SCM 05) Registration letter is required before commercialization. RA 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 LIMS. QC
|
| 1) Aug-25
2) July-25
3) July-25
4) July-25
5) July-25
6) Aug-25
7) Aug-25
8) July-25
9) July-25
| 27/05/2025 | 04/07/2025 | Hamza Ahmed | Hamza Ahmed |
|
| CMP-0097-25 | 27/05/2025 | BD | Permanent | Minor | Launch of levetiracetam Tablets 500mg (3x10’s) in Philippines. | This product is not launched in Philippines yet. | The product levetiracetam Tablets 500mg (3x10’s) is planned for launch in Philippines. | N/A | Approved | 30/09/2025 | In Progress | Pharma | 01) Planning of product launch for commercial. BD
02) Development and approval artwork(U/C, A/F and D/I).
BD
03) Item code will be opened. BD
04) FG code will be opened. SCM
05) Registration letter is required before commercialization. RA
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 LIMS. QC
|
| 1) Sep-25
2) July-25
3) July-25
4) June-25
5) Sep-25
6) Sep-25
7) Aug-25
8) Sep-25
| 27/05/2025 | 05/07/2025 | Hamza Ahmed | Hamza Ahmed |
|
| CMP-0098-25 | 29/05/2025 | SCM | Permanent | Minor | Alternate source of WFI 10ml and 5ml from Macter International for Parabactum injection 500mg, 1gm and 2gm. | Currently, Water for Injection (WFI) sourced from Surge and Cunningham Pharmaceuticals is used for the Parabactum injection 500mg, 1gm and 2gm. Parabactum injection is toll-in manufacturing product for Martin Dow Ltd. | With reference to the change proposed by MDL, alternate source of WFI 10ml and 5ml from Macter International is to be developed and utilized in the Parabactum injection 500mg, 1gm and 2gm. | N/A | Approved | 31/07/2025 | In Progress | Pharma | 01) Quality agreement is required from MDL. SCM
02) Details of WFI are required to print on the unit carton. SCM
|
| 1) July-25
2) July-25
| 29/05/2025 | 05/07/2025 | Hamza Ahmed | Hamza Ahmed |
|
| CMP-0099-25 | 30/05/2025 | Production | Permanent | Minor | Addition of new roller compactor in the batch document in place of old roller compactor at slugging stage. | Currently old roller compactor is mentioned in the batch document Dry Granulator Compactor | It is proposed to update the batch documents as per current model and ID of roller compacter
Equipment: LGP200 ROLLER COMPACTOR
| N/A | Approved | 31/08/2025 | In Progress | Pharma | Batch documents will be revised.
|
| Aug-25
| 02/06/2025 | 05/07/2025 | Hamza Ahmed | Hamza Ahmed |
|
| CMP-0100-25 | 30/05/2025 | SCM | Permanent | Minor | Change intimation for Bisoprolol Fumarate by API Manufacturer M/s: Mehta API Pvt Ltd. | We have approved supplier and manufacturer for Bisoprolol Fumarate by the name of M/s Mehta API Pvt Ltd. | This is to inform you that Mehta API Pvt Ltd has done the equipment change for Bisoprolol Fumarate.
(Change Intimation from supplier is attached for reference) | N/A | Approved | | Closed | Pharma |
| As per impact assessment no any action is required. therefore this change is closed.
|
| 02/06/2025 | 05/07/2025 | Hamza Ahmed | Hamza Ahmed |
|
| CMP-0101-25 | 05/06/2025 | QC | Permanent | | Change in specification of raw material Nebivolol HCl from in-house specification to EP. | Currently, the specification for the API raw material (Nebivolol HCl) from the manufacturers Zhejiang Huahai Pharmaceuticals, Hema Pharmaceuticals Pvt Ltd, Cadila Pharma India, Abhilash India and Smaart Pharmaceuticals are based on in house claim. | It is proposed to revise the specification of Nebivolol HCl from in-house specification to EP. | N/A | under Approval | | | Pharma |
|
|
| 05/06/2025 | 11/06/2025 | Hamza Ahmed | Hamza Ahmed |
|
| CMP-0102-25 | 10/06/2025 | SCM | Permanent | Major | Additional source induction for Active Pharmaceutical ingredient
Zinc Sulphate Monohydrate.
| Our current approved source M/s. Dr Paul Lohmann, Germany has withdrawn WHO-APIMF of Zinc Sulphate Monohydrate from WHO. | It is proposed to induct M/S. CANTON LABORATORIES PVT. LTD Add: VILL. MUJPUR, TA. PADRA, DIST. VODODARA - 391 440, INDIA for Zinc Sulphate Monohydrate. | RA-0025-25 | Approved | 31/10/2025 | In Progress | Pharma | 01) Qualification of new API source manufacturer
(Canton Laboratories). QA
02) API Ordering from Canton Laboratories. SCM
03) Variation submission for change in API source, in WHO. RA
04) Vendor list will be updated. QA
05) Source name will be added in LIMS. QC
06) Receipt of material at site. SCM
07) Testing of material. QC
08) Manufacturing of batches for process validation. Production
09) Process validation will be performed. Validation
10) Stability studies will be performed on validation batches (Long term and Accelerated stability studies). QC
|
| 1) Done
2) Done
3) Aug-25
4) July-25
5) Aug-25
6) Aug-25
7) Sep-25
8) Oct-25
9) Oct-25
10) Oct-25
| 10/06/2025 | 05/07/2025 | Hamza Ahmed | Hamza Ahmed |
|
| CMP-0103-25 | 17/06/2025 | PD | Permanent | | Replacement of coating material from Opadry White II 85G68918 to Sheffcoat PVA White (5Y01440) in Products List attached | Currently Opadry White II 85G68918 is used as a coating material in the list of product attached.
| To It is proposed to replace the existing coating material, Opadry White II 85G68918, with Sheffcoat PVA White (5Y01440) in the products specified in the attached list.
Opadry White II 85G68918
Polyvinyl Alcohol
Titanium Dioxide
Talc
Polyethylene Glycol / Macrogol
Lecithin (Soy)
15% dispersion in Water
Sheffcoat PVA White (5Y01440)
Polyvinyl Alcohol
Titanium Dioxide
Talc
Polyethylene Glycol / Macrogol
Soya Lecithin
20% dispesion in Water
| N/A | under Approval | | | Pharma |
|
|
| 17/06/2025 | 20/06/2025 | Hamza Ahmed | Hamza Ahmed |
|
| CMP-0104-25 | 17/06/2025 | PD | Permanent | Major | New launch product vericiguat 10mg, 5mg and 2.5mg Tablet | Product development activities of generic Vericiguat 10mg, 5mg and 2.5mg Tablet has been completed. | It is proposed to commercialize Vericiguat 10mg, 5mg and 2.5mg Tablet in pharmevo facility. | RA-0026-25 | Approved | 30/06/2026 | In Progress | Pharma | 01) Trail documents are required. PD
02) Stability study documents are required. PD
03) Containment Approach and cleanability report is required. PD
0) Technology transfer protocol (for process) is required. PD
05) Technology transfer protocol (for analytical testing) is required. PD
06) Source approval documents is required. SCM
07) Procurement of required raw materials i.e. vericiguat. SCM
08) Artwork will be developed and approved. BD
09) Item codes will be opened for new developed artwork. BD
10) Specification of packaging material will be developed QC
11) FG code will be opened. SCM
12) Procurement of packaging material. SCM
13) Analytical testing method will prepare and update on LIMS. QC
14) BOM will be create in SAP. QA
15) Batch documents (BDR, BMR, BYS, BPR) will be prepared. QA
16) Routing will be created in SAP. Production
17) Planning of product launch for commercial. BD
18) Process validation will be performed. QA(Val)
19) Product will be charge on stability. QC
|
| 1) Done
2) Done
3) Oct-25
4) Oct-25
5) Oct-25
6) Aug-25
7) Oct-25
8) Aug-25
9) Aug-25
10) Oct-25
11) July-25
12) After BOM creation
13) Nov-25
14) Sep-25
15) Nov-25
16) Nov-25
17) Nov-25
18) June-26
19) June-26
| 17/06/2025 | 05/07/2025 | Hamza Ahmed | Hamza Ahmed |
|
| CMP-0105-25 | 17/06/2025 | RA | Permanent | Minor | Inclusion of NAFDAC REG. NO on the primary, secondary and tertiary packaging container of the finished drug product | The NAFDAC REG. NO. is only included / printed on secondary product packaging container for all the products registered in Nigeria | Inclusion of NAFDAC REG. NO on all the primary, secondary and tertiary container for FPP. | N/A | Approved | 30/09/2025 | In Progress | Pharma | 01) NAFDAC REG No will be printed on primary, secondary and tertiary containers in all Nigeria products. Production
|
| 01) Immediately for Nigeria products.
| 17/06/2025 | 05/07/2025 | Hamza Ahmed | Hamza Ahmed |
|
| CMP-0106-25 | 17/06/2025 | SCM | Permanent | | Additional source induction of Formoterol Fumarate Dihydrate For DPI | We are currently procuring API: Formoterol Fumarate Dihydrate For DPI from M/S. Vamsi Labs Ltd.,India | We intend to induct one more source M/s. BEIJING BREATHGREEN HEALTHCARE CO.L
Add: No.18 Huashan Road East,Chemical Industry Park,Eshan Town, Yicheng District, Zaozhuang City, Shandong Province, China
| N/A | under Approval | | | Pharma |
|
|
| 17/06/2025 | 20/06/2025 | Hamza Ahmed | Hamza Ahmed |
|
| CMP-0107-25 | 17/06/2025 | SCM | Permanent | | Additional source induction of Fluvoxamine Maleate | We are currently procuring API: Fluvoxamine Maleate from M/S. Lake Chemicals Pvt Ltd, India & M/s. Cohance Lifesciences Ltd. India | We intend to induct one more source M/s. SHANDONG RISEN-SUN PHARMA
Add: No.3577 of Peitianmen Street, Taian High-Tech Industrial Development Zone Shandong Province, China,
| N/A | under Approval | | | Pharma |
|
|
| 17/06/2025 | 20/06/2025 | Hamza Ahmed | Hamza Ahmed |
|
| CMP-0108-25 | 17/06/2025 | SCM | Permanent | | Additional source induction of Vonoprazan Fumarate | We are currently procuring API: Vonoprazan Fumarate from M/S. Ami Lifescience Pvt.Ltd. India | We intend to induct one more source M/s. ENANTIOTECH CORPORATION LTD.
Add: No. 06 Zhongjing Road, Torch Developemt Zone, Zhongshan City,Guangdong Province, China (528437)
| N/A | under Approval | | | Pharma |
|
|
| 17/06/2025 | 20/06/2025 | Hamza Ahmed | Hamza Ahmed |
|
| CMP-0109-25 | 17/06/2025 | SCM | Permanent | | Additional source induction of Budesonide For DPI | We are currently procuring API: Budesonide For DPI from M/S. Vamsi Labs Ltd., India | We intend to induct one more source M/s. BEIJING BREATHGREEN HEALTHCARE CO.L
Add: No.18 Huashan Road East,Chemical Industry Park,Eshan Town, Yicheng District, Zaozhuang City, Shandong Province, China
| N/A | under Approval | | | Pharma |
|
|
| 17/06/2025 | 20/06/2025 | Hamza Ahmed | Hamza Ahmed |
|
| CMP-0110-25 | 18/06/2025 | SCM | Permanent | Minor | Less than 90% compression tooling (Dies & Punches) | Currently we have less than 90% compression tooling (Dies & Punches) for different products as per attached list in Production Non-Cephalosporin area. | It is proposed to allow the compression process for the products mentioned in the attached list with less compression tolling (Less than 90%) | RA-0024-25 | under Approval | | | Pharma |
|
|
| 19/06/2025 | 05/07/2025 | Hamza Ahmed | Hamza Ahmed |
|
| CMP-0111-25 | 20/06/2025 | QA | Permanent | Minor | Induction of New Instrument Conductivity meter Model SD30 of Mettler Toledo in QA IPC Lab (Non-Ceph). | Currently we have Conductivity Meter inoLab 7310P in IPC Lab Non-Ceph Area. | Currently we have Conductivity Meter inoLab 7310P in IPC Lab Non-Ceph Area. This instrument was shifted from IPC Lab Non-Ceph to IPC Lab Nutra Section. New procured Conductivity meter Model SD30 of Mettler Toledo will be installed in IPC Lab Non-Ceph Area. | | under Approval | | | Pharma |
|
|
| 21/06/2025 | 05/07/2025 | Hamza Ahmed | Hamza Ahmed |
|
| CMP-0112-25 | 20/06/2025 | PD | Permanent | Major | Change in formulation of Byvas 10mg, 5mg and 2.5mg tablet to improve similarity factor in Comparative dissolution profile (CDP). | Currently batch is being manufactured in accordance to the formulation mentioned in annexure-1.
Existing formulation contain M.C. cellulose #PH-102, Lactose Monohydrate, maize starch, H.P.M.C, cross carmellose sodium, colloidal silicon dioxide, magnesium stearate.
Tablet weight of Byvas 10mg, 5mg and 2.5mg are 300mg/tablet ,230mg and 115mg respectively.
| Batch will be manufactured in accordance to the formulation mentioned in annexure-1.
H.P.M.C from the existing formulation has been replaced with polysorbate 80 and M.C. cellulose #PH-102 has been replaced by M.C. cellulose #PH-101.
Tablet weight of Byvas 10mg, 5mg and 2.5mg will be 250mg/tablet ,250mg and 125mg respectively.
b | | under Approval | | | Pharma |
|
|
| 21/06/2025 | 05/07/2025 | Hamza Ahmed | Hamza Ahmed |
|
| CMP-0113-25 | 30/06/2025 | PD | Permanent | Major | Change in formulation of Gouric 80mg and 40mg tablet to improve similarity factor in Comparative dissolution profile (CDP). | • Currently batch is being manufactured in accordance to the formulation mentioned in annexure-1.
• Existing formulation contains M.C. cellulose #PH-102, Tablettose 80, Klucel-LF, quinoline yellow, Lake brilliant blue FCF, cross carmellose sodium, colloidal silicon dioxide, magnesium stearate, talcum powder.
• Batch is manufactured using slugging process.
• Tablet weight of Gouric 80mg and 40mg are 300mg/tablet and 200mg respectively.
• Tablets of Gouric 80mg and 40mg are being compressed round 10mm round 7mm punch
| • Batch will be manufactured in accordance to the formulation mentioned in annexure-1.
• Tablettose 80mg have been replaced with lactose monohydrate and talcum powder is removed. Quantitative changes in composition will be done.
• Batch will be manufactured using wet granulation.
• Tablet weight of Gouric 80mg and 40mg will be 500mg/tablet and 250mg/tablet respectively.
• Tablets of Gouric 80mg and 40mg will be compressed at oval 13.9 x 8.2mm and round 9mm punch respectively.
| | under Approval | | | Pharma |
|
|
| 30/06/2025 | 05/07/2025 | Hamza Ahmed | Hamza Ahmed |
|
| CMP-0114-25 | 30/06/2025 | BD | Permanent | Minor | Ivadin 5mg (14,s) for SPC tender In Sri Lanka | Ivadin(Ivabradine) 5mg is not provided through SPC tender in Sri Lanka. | Ivadin(Ivabradine) 5mg will be provided through SPC tender in Sri Lanka. | | under Approval | | | Pharma |
|
|
| 30/06/2025 | 05/07/2025 | Hamza Ahmed | Hamza Ahmed |
|
| CMP-0115-25 | 30/06/2025 | QA | Permanent | Minor | Induction of New Instrument Weighing Balance MA-204 Mettler Toledo with Printer in IPC Lab Cephalosporin Section. | Currently No weighing balance available in IPC Lab Cephalosporin Section. | Induction of New Instrument Weighing Balance MA-204 Mettler Toledo with Printer in IPC Lab Cephalosporin Section. | | under Approval | | | Pharma |
|
|
| 30/06/2025 | 05/07/2025 | Hamza Ahmed | Hamza Ahmed |
|
| CMP-0116-25 | 02/07/2025 | QA | Permanent | Minor | Implementation of In-House Printing of Batch Number, Manufacturing Date, and Expiry Date on OPT-D Injection Ampoules by M/s. Saffron Pharma | Currently, ampoules of OPT-D Injection are received by M/s. Saffron Pharma from their packaging supplier with preprinted batch number, manufacturing date, and expiry date. | M/s. Saffron Pharma will now arrange the ampoules without batch number, manufacturing date, and expiry date from the their supplier. These details will be printed in-house by Saffron Pharma at the time of batch packaging.
Attached artwork versions (with and without printing)
| | under Approval | | | Pharma |
|
|
| 02/07/2025 | 05/07/2025 | Hamza Ahmed | Hamza Ahmed |
|
| CMP-0117-25 | 02/07/2025 | SCM | Permanent | Major | Additional source induction of Vildagliptin | We have approved sources for Vildagliptin as M/s Jiangxi Synergy & Ms. Aparna Organics. | We intend to induct one more source M/s. Fuxin Long Rui Pharmaceutical Co., Ltd.
Fluoride Industrial Park, Fumeng County ( Yi Ma Tu ), Fuxin City, Liaoning Province -123000, China.
| | under Approval | | | Pharma |
|
|
| 02/07/2025 | 05/07/2025 | Hamza Ahmed | Hamza Ahmed |
|
| CMP-0118-25 | 03/07/2025 | BD | Permanent | Minor | Change of material Description of HPMC # 3 Shell Glyco + Indac M 50/110mcg Material No 1100000436 | Currently material description of Material No 1100000436 is HPMC # 3 Shell Glyco + Indac M 50/110mcg. One of this material has been received and released by QC after testing.
GRN No : 5000114922
QC Lot No: 10000071466
Lot Qty: 1000000 Shells | It is proposed to change the material Description of Material No 1100000436 to HPMC # 3 Shell Glyco + IA +Momet 50/150/60mcg. Same testing shall be applicable. | | under Approval | | | Pharma |
|
|
| 04/07/2025 | 05/07/2025 | Hamza Ahmed | Hamza Ahmed |