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| RA-0001-24 | 03/01/2024 | PD | To identify the risk associated with relaunch of product Securin (Amlodipine) 5 and 10 mg and new launch of 2.5mg tablet | Medium | Low | 1) Technology transfer protocol will be prepared
2) process validation will perform QA (val)
product will charge on stability
1) Feb -2024 2) Feb-2024
| 29/02/2024 | completed | Accepted | 03/01/2024 11:03:34 | 10/05/2024 22:11:19 | Hafsa Fatima | Hafsa Fatima |
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| RA-0002-24 | 03/01/2024 | PD | To identify the risk associated with the technology transfer of Parasugrel 5mg and 10mg tablet from product development department to Pharmevo manufacturing facility(Production). | Medium | Low | 1. ADE/PDE value will be obtained, and containment approach will be applied. Cleanability studies will be performed.
2. Trail will be conducted, and stability will be conducted.
3. Training will be provided 4. Process Validation will be performed. 5) Alternate source of Prasugrel will be developed | 30/06/2025 | Not implemented due to change control has been closed without implementation. | Accepted | 03/01/2024 12:07:12 | 31/08/2024 22:13:20 | Hafsa Fatima | Zafran Meer |
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| RA-0003-24 | 03/01/2024 | Production | Non-ceph | To identify the risk associated with the procedure of reworking of Avsar plus 160/10/25Tab. | medium | Low | Stability will be performed | 30/04/2026 | Stability on going | Accepted | 03/01/2024 09:30:49 | 20/03/2024 20:37:18 | Hafsa Fatima | Hafsa Fatima |
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| RA-0004-24 | 16/01/2024 | SCM | To identify the risk associated with induction of new source of Empty Hard Gelatin Capsule shell from M/s. health capsule Pakistan . | Medium | Low | 1.Vendor list will be updated
2.Process validation will be performed
3.PV batches will be charged on stability | 31/07/2024 | 1. April-2024
2. Extension taken for Process Validation till Dec-24 and for stability till Jan-25 | Accepted | 16/01/2024 09:16:08 | 07/03/2024 22:16:20 | Hafsa Fatima | Hafsa Fatima |
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| RA-0005-24 | 22/01/2024 | Production | Risk Associated with The Extension of Shelf-Life of Finished Product | Low | N/A | N/A | N/A | N/A | Accepted | 22/01/2024 09:16:55 | 25/01/2024 17:22:08 | Hafsa Fatima | Hafsa Fatima |
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| RA-0006-24 | 22/01/2024 | QA | Risk associated with User Required specification (URS) | Medium | Low | URS SOP will be prepared | 31/05/2024 | action plan executed | Accepted | 22/01/2024 09:27:27 | 05/07/2024 17:27:43 | Hafsa Fatima | Hafsa Fatima |
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| RA-0007-24 | 01/02/2024 | Micro | To identify the risk associated with the Installation of Double door Autoclave in ceph area | Medium | Low |
1) Qualification will be performed.
2) SOP will be prepared and training will be provided
3) bowie dick test will be part of PQ
4) SOP will be prepared and training will be provided
| 31/05/2024 | SOP of URS has been prepared.
For qualification Extension timeline has been taken till Sep-2024 | Accepted | 01/02/2024 09:07:16 | 06/06/2024 22:20:27 | Hafsa Fatima | Hafsa Fatima |
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| RA-0008-24 | 02/02/2024 | Production | To identify the risk associated with the Use of Roller compactor in Sacvin 200mg Tablet. | Medium | Low | 1. Process validation will be performed
2. Product will be charged on stability
3.BMR will be revised after completion of PV | 29/11/2024 | In progress | Accepted | 02/02/2024 11:29:25 | 15/02/2024 22:22:49 | Hafsa Fatima | Hafsa Fatima |
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| RA-0009-24 | 14/02/2024 | QA | To identify the risk associated with To identify potential risk associated with the presence of diethylene glycol (DEG) and ethylene glycol (EG) impurity in syrup products. | Medium | Low | 1. Sorbitol 70% Solution and Glycerin will be procured only from those supplier who provide the Testing results of DEG/EG impurity
Approved Vendor will be revised to exclude the following suppliers
Sara Enterprises
Mehran Chemical
Maya Corporation
2. SOP of supplier qualification shall be revised to include the requirement that supplier must be capable to detect the presence of impurity in Sorbitol 70% Solution and Glycerin.
3. Material will be procured from direct importer.
4.Currently Sorbitol 70% Solution and Glycerin received in Blue color Drums having seal lock.
Vendor authentication is required on seal.
5. QC lot No. 0000027997 will be Hold in SAP till satisfactory results of DEG/EG impurity.
6. DEG/EG impurity testing will be performed on QC lot No. 0000027997 procured from Mehran Chemical
7. For verification three batches of each product will be Tested for DEG & EG impurity.
| 30/06/2024 | 1.Done
2. Done
3. Done
4.Done
5.Done
6. Done
7. Done | Accepted | 14/02/2024 12:02:09 | 21/11/2024 09:15:26 | Hafsa Fatima | Zafran Meer |
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| RA-0010-24 | 21/02/2024 | PD | To identify and assess the risk associated with the new launch product and technology transfer of Trelagliptin succinate 50mg and 100mg Tablet from product development department to pharmevo manufacturing facility (Production) | Medium | Low | 1) ADE/PDE value will be obtained, and containment approach will be applied cleanability studies will be performed
and Training will be provided
2) Parameters and specification limits will be finalized after completion of process validation 3) Cleaning validation will be performed 4)Alternate source of Trelagliptin will be developed. | 31/12/2025 | Extension timeline has been taken on cleanibility study till Oct-2024 and other actions will be completed till Dec-25 | Accepted | 21/02/2024 09:22:10 | 01/04/2024 22:31:23 | Hafsa Fatima | Hafsa Fatima |
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| RA-0011-24 | 21/02/2024 | Production | To identify the risk associated with the 2D barcode & serialization management system | Medium | Low | 1)SOP will be revised to incorporate procedure for art-work designing accordingly
2) Query will be shared with vendor to incorporate the required information. For the time being DRAP (Drug Regulatory Authority of Pakistan) Barcode Scanner will be used through mobile application. 3) Training will be conducted to concerns staff to ensure that Challenge test must be verified and documented. 4)Verification after any breakdown 5)SOP will be revised to incorporate the statement that after any breakdown initial unit carton verified by Production designee and QAI and it will be part of batch document.
Challenge test should be performed and documented accordingly | 31/10/2024 | 1. Done 2)Oct- 24 3) Done 4) Done 5) Done | Accepted | 21/02/2024 17:02:36 | 05/09/2024 22:33:59 | Hafsa Fatima | Zafran Meer |
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| RA-0012-24 | 29/02/2024 | Engineering | To identify the risk associated with Upgradation in layout of non ceph production area to accommodate new machines and to improve GMP compliance. | Low | N/A | 1) Facility Qualification will be caried out prior to starting of area operations 2) Segregated processing areas by cordoning off production areas prior to working to prevent any contamination 3) All the machines will be re qualify after shifting to designated area as part of procedure 4) Segregation of finished product (Cold room) 5) For cold storage thermal mapping to be performed at the time of qualification | 31/12/2024 | In progress
1) Done 2) Done 3) Dec-24 4) Done 5) Done | Accepted | 29/02/2024 12:44:13 | 30/08/2024 22:39:14 | Hafsa Fatima | Zafran Meer |
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| RA-0013-24 | 29/02/2024 | WH | To identify the risk associated with change in unit of Quinoline yellow from Kg to grams | Medium | Low | 1. New code will be open in g.
2. Material will be procured in Kg and quantities will be transfer to new code.
3. Communication will be provided to all stake holders
4. SOP of material receiving will be revised to incorporate these controls
5. SAP BOM and BDR will be revised to update the new material code | 30/04/2024 | In progress
Extension taken till Dec 2024 | Accepted | 29/02/2024 09:11:05 | 02/05/2024 22:41:50 | Hafsa Fatima | Hafsa Fatima |
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| RA-0014-24 | 04/03/2024 | Engineering | To identify the risk associated with Re-location of supply grill in liquid manufacturing area Non-ceph | Medium | Low | 1) Removal of old supply grills will be carried out during non production hrs. Area will be cordon off during this work. Old location of supply grill will be properly closed before installation to new location. 2) Cleaning of the area will be performed before and after relocation. 3) All working will be caried out with proper planning. Activity will be communicated to all stake holders. 4) All engineering work will be carried out by trained engineering staff. 5) Area qualification will be performed as per procedure. all the checks will be included in area qualification i.e. Air flow pattern, CFM Count, Monitoring of environmental condition i.e. RH, Temp and Differential Pressure, Viable and non-viable count | 31/05/2024 | Completed | Accepted | 04/03/2024 14:14:22 | 20/05/2024 22:45:19 | Hafsa Fatima | Hafsa Fatima |
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| RA-0015-24 | 12/03/2024 | Engineering | To identify the risk associated with Risk associated with Water System. | Low | N/A | N/A | N/A | N/A | Accepted | 12/03/2024 08:05:40 | 21/03/2024 22:46:42 | Hafsa Fatima | Hafsa Fatima |
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| RA-0016-24 | 20/03/2024 | PD | To identify the risk associated with Risk associated with change in formulation of Dapwiz plus XR tablets (process improvement) | Medium | Low | 1) PV will be performed
2)Batches will be charged on stability | 31/12/2024 | In-Progress | Accepted | 20/03/2024 11:09:18 | 26/03/2024 22:48:11 | Hafsa Fatima | Hafsa Fatima |
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| RA-0017-24 | 01/04/2024 | Quality Assurance | Risk Associated with personal Hygiene | Low | N/A | N/A | N/A | N/A | Accepted | 01/04/2024 08:11:26 | 03/04/2024 23:49:28 | Hafsa Fatima | Hafsa Fatima |
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| RA-0018-24 | 01/04/2024 | Production/Non-Ceph | To identify the Risk associated with Shifting of compression machine T-700 and ZP37B-1 | Medium | Low | 1)1)Both machines will be installed respectively
2)Requalification of both machines will be performed.
3) Re-calibration of both machines will be conducted | 28/06/2024 | Action plan has been executed | Accepted | 01/04/2024 08:55:44 | 30/05/2024 22:50:40 | Hafsa Fatima | Hafsa Fatima |
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| RA-0019-24 | 16/04/2024 | PD | Addition of compaction process in Diu-Tansin from wet granulation to compaction to improve hardness of tablet in batch # 4C032, 4C064 and 4C065 | High | N/A | N/A | N/A | N/A | Not accepted , closed without implementation | 16/04/2024 15:53:09 | 23/04/2024 22:52:07 | Hafsa Fatima | Hafsa Fatima |
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| RA-0020-24 | 17/04/2024 | Production | To identify the Risk associated with Risk on dispensing of Campaign Batches. | Low | N/A | N/A | N/A | N/A | Accepted | 17/04/2024 15:06:17 | 26/04/2024 22:52:54 | Hafsa Fatima | Hafsa Fatima |
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| RA-0021-24 | 18/04/2024 | Production | Non-ceph | To identify the Risk associated with Risk on installation of new Hoonga Blister Machine (Auto-Cartoner). and transferring of products to Hoonga blister machine. | Medium | Low | 1-Two New blister cubicles will be created.
2-BM350 B and C will relocate to a new cubicle respectively and qualification will be performed.
3-The Hoonga blister machine will be installed in cubicle-1 & Cubicle-2 respectively
4-IQ, OQ will be performed
5. PQ will be performed 6. New equipment will be added in calibratin master list. 7. SOP of blister machine will be developed after qualification of equipment and training of SOP will be provided. 8. All safety checks will be verified during qualification. 9. Dimension will be changed in accordance with the required dimensions of the tool of Hoonga blister machines. Eg auminium foil, Unit carton and DI. 10. Product will be shifted to hoonga blister machine after consumption of existing inventory. 11. Packaging material new code will be opened for products shifted to hoonga blister machine. 12. SAP BOM and PO (BPR) will be revised accordingly | 31/07/2025 | 1. Done 2)Done 3) Done 4) Done 5) Dec-24 6) oct-24 7)Done 8)Done 9)Done 10) Mar-2025 11) Done 12) Apr-25 | Accepted | 18/04/2024 15:06:43 | 02/08/2024 22:57:13 | Hafsa Fatima | Zafran Meer |
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| RA-0022-24 | 18/04/2024 | Quality Assurance | To identify the risk associated with halal assurance system | Medium | Low | Halal Standard clauses should be added in the Self-Inspection SOP QAG/2/036. | 30/10/2024 | Inprogress | Accepted | 23/04/2024 09:53:41 | 29/04/2024 08:45:42 | Hafsa Fatima | Zafran Meer |
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| RA-0023-24 | 29/04/2024 | QA | To identify the Risk associated with Manufacturing of commercial batches of ZI-AD Syrup. | Medium | Low | 1. Parameters and specification limits will be finalize after completion of process validation 2. Cleaning Validation to be performed at commercial stage 3.Finished product Samples will be send to outsource lab for NDMA testing 4.Supply chain to develop alternate source | 31/12/2024 | In-progress | Accepted | 29/04/2024 10:30:33 | 26/06/2024 23:03:18 | Hafsa Fatima | Hafsa Fatima |
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| RA-0024-24 | 29/04/2024 | QA | To identify the Risk associated with Manufacturing of commercial batches of ZI-AD 20mg dispersible Tablet | Medium | Low | 1) Cleanability will be performed.
2) Parameters and specification limit will be finalized after completion of process validation.
3) Cleanability to be performed
4) Finished product Samples will be tested for NDMA testing
5.Supply chain to develop alternate source of API | 31/12/2024 | In-progress | Accepted | 29/04/2024 10:31:29 | 09/05/2024 23:06:17 | Hafsa Fatima | Hafsa Fatima |
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| RA-0025-24 | 17/05/2024 | QA-Val | To identify the risk associated with handling of antibiotic waste produce from both cephalosporin area and Non-cephalosporin , the risk assessment covers the receiving of antibiotics, dispensing, manufacturing process, compression, coating and blistering process and after washing risk of all antibiotic scope areas. | Medium | Low | Production will inform to EHS after washing of area in which antibiotic will process and QC will perform the testing. | 30/09/2024 | In-progress | Accepted | 17/05/2024 15:35:43 | 29/05/2024 01:31:21 | Hafsa Fatima | Hafsa Fatima |
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| RA-0026-24 | 14/06/2024 | Production | To identify the Risk associated with Risk related to Mix-up of product at Granulation/Compression/
Core/Coated stage. | Low | N/A | N/A | N/A | N/A | Accepted | 14/06/2024 15:28:05 | 24/06/2024 23:10:19 | Hafsa Fatima | Hafsa Fatima |
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| RA-0027-24 | 24/06/2024 | Product development | To identify the Risk associated with change of batch size of Actiflor Sachet, change in environmental conditions in manufacturing and filling areas. | Medium | Low | 1) Saccharomyees Bolurdii will be procured in 10kg pack size only. 2) Environmental conrols to be maintain at temperature 20 degree ± 2 degree and RH 35% ± 5% during , manufacturing and filling of actiflor sachet. 3) Area qualififcation of manufacuturing and sachet filling areas to be performed 4) Control for nitrogen cylinder will be installed. 5) Oxygen testing in sachet will be done for finish product .
6) Batch Document to be revised. | 28/02/2025 | In-Progress | Accepted | 24/06/2024 17:03:01 | 27/06/2024 23:16:28 | Zafran Meer | Zafran Meer |
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| RA-0028-24 | 24/06/2024 | Product development | To identify and assess the risk associated with formulation change in Finno-Q Sachet | Medium | Low | 1. Process validation will be performed.
2. Complete documents of stability studies of trails to be provided.
3. Pv batches will be charged on stability. | 31/03/2025 | In-progress | Accepted | 28/06/2024 12:12:31 | 09/07/2024 01:41:26 | Zafran Meer | Zafran Meer |
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| RA-0029-24 | 08/07/2024 | Production | To identify the Risk associated with Installation of walking chamber in QC. | Medium | Low | 1. IQ, OQ and PQ will be performed
2. SOP will be updated to incorporate all actions
3. Training will be provided to QC concern staff. | 30/09/2024 | Completed | Accepted | 08/07/2024 12:40:50 | 13/09/2024 10:47:34 | Hafsa Fatima | Zafran Meer |
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| RA-0030-24 | 08/07/2024 | Production | To identify the Risk associated with Sterile Operations in Cephalosporin Area | Low | N/A | N/A | N/A | N/A | Accepted | 08/07/2024 11:52:44 | 12/07/2024 23:30:37 | Hamza Ahmed | Zafran Meer |
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| RA-0031-24 | 21/08/2024 | Validation | Risk related to Qualification and Validation | Medium | Low | 1) SOP of raw material release will be revise to incorporate the procedure. 2) Software based system control will be develop for automatic intimation and tracking of bulk hold time study. | 28/02/2025 | In-Progress | Accepted | 21/08/2024 09:03:37 | 22/08/2024 23:32:12 | Zafran Meer | Zafran Meer |
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| RA-0032-24 | 21/08/2024 | QC | To identify the risk associated with new launch of product Shifting from data reporting software LIMS to SAP for Ceph and Non-Ceph QC Laboratory
| In-progress | | | N/A | | | 19/09/2024 11:47:45 | 14/11/2024 16:56:22 | Zafran Meer | Zafran Meer |
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| RA-0033-24 | 19/09/2024 | PD | To identify the Risk associated with new launch of product vonoprozan fumarate | | | | N/A | | Inprogress | 19/09/2024 11:53:51 | 14/11/2024 16:55:32 | Zafran Meer | Zafran Meer |
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| RA-0034-24 | 28/09/2024 | PD | To identify the risk associated with new launch of product Increase in batch size of Aprep 80mg Capsule and Combo pack of Aprep 80mg and Aprep 125mg Capsule | | | | N/A | In-Progress | | 28/09/2024 09:24:38 | | Hamza Ahmed | |
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| RA-0035-24 | 28/09/2024 | PD | To identify the risk associated with new launch of product Cholestyramine 4mg Sachet | | | | N/A | In-Progress | | 28/09/2024 09:24:42 | | Hamza Ahmed | |
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| RA-0036-24 | 28/09/2024 | SCM | Risk associated with Handling of loan material | In-progress | | | N/A | | | 10/10/2024 17:22:26 | 21/10/2024 10:15:27 | Zafran Meer | Zafran Meer |
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| RA-0037-24 | 10/10/2024 | PD | Risk associated with release of Bisoprolol QC Lot number 49756 with larger PSD | In-progress | | | N/A | | | 10/10/2024 17:23:35 | 21/10/2024 10:13:45 | Zafran Meer | Zafran Meer |
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| RA-0038-24 | 18/10/2024 | QA- Validation | New launch of Bempedoic acid 180mg Tablet | in-progress | | | N/A | | | 18/10/2024 12:13:48 | 21/10/2024 10:13:13 | Zafran Meer | Zafran Meer |
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| RA-0039-24 | 21/10/2024 | QA-Validation | Risk related to Transport Validation | In-progress | | | N/A | | | 21/10/2024 10:12:36 | | Zafran Meer | |
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| RA-0040-24 | 24/10/2024 | PD | Risk associated with new launch of Letrozole 2.5mg Tablet | In-progress | | | N/A | | | 24/10/2024 09:14:00 | | Zafran Meer | |
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| RA-0041-24 | 24/10/2024 | PD | Risk associated with new launch of Bempedoic acid/ Ezetimibe 180/10mg tablet | In-progress | | | N/A | | | 24/10/2024 09:15:54 | | Zafran Meer | |
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| RA-0042-24 | 24/10/2024 | Production (Nutraceutical) | Risk associated with implementation of automation where master carton labels will be directly printed from SAP system | In-progress | | | N/A | | | 24/10/2024 09:17:52 | | Zafran Meer | |
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| RA-0043-24 | 24/10/2024 | QC | Risk associated with the current practice of placement of probe in Autoclave
| In-progress | | | N/A | | | 02/11/2024 15:55:23 | | Zafran Meer | |
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| RA-0044-24 | 24/10/2024 | Warehouse | Risk associated with the impact of unclassified lift in class D area adjacent to class D corridor of the dispensing area.
| In-progress | | | N/A | | | 02/11/2024 15:56:55 | | Zafran Meer | |
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| RA-0045-24 | 14/11/2024 | PD | Risk associated with New launch of Carbidopa+ Levodopa CR 25/100mg Tablets in PharmEvo premises
| In-progress | | | N/A | | | 14/11/2024 16:42:13 | | Zafran Meer | |
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| RA-0046-24 | 14/11/2024 | PD | Risk associated with New product launch of Carbidopa+ Levodopa IR 12.50/50mg tablets, Carbidopa+ Levodopa IR 25/250mg tablets, Carbidopa+ Levodopa IR 25/100mg tablets
| In-progress | | | N/A | | | 14/11/2024 16:43:52 | | Zafran Meer | |
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| RA-0047-24 | 14/11/2024 | PD | Risk associated with New Launch product Glycopyrronium +Indacaterol 110/50mcg DPI Capsule
| In-progress | | | N/A | | | 14/11/2024 16:44:38 | | Zafran Meer | |
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| RA-0048-24 | 14/11/2024 | PD | Risk associated with New Launch product Finerenone 10mg and 20mg Tablet
| In-progress | | | N/A | | | 14/11/2024 16:45:24 | | Zafran Meer | |
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| RA-0049-24 | 14/11/2024 | PD | New Launch Fluticasone propionate/Salmeterol 500/5mcg, 250/50mcg & 100/20mcg DPI capsule
| In-progress | | | N/A | | | 14/11/2024 16:45:57 | | Zafran Meer | |
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| RA-0050-24 | 14/11/2024 | QC | Risk associated with installation of Equipment in QC Lab | In-progress | | | N/A | | | 14/11/2024 16:48:20 | | Zafran Meer | |
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| RA-0051-24 | 14/11/2024 | QC | Risk associated with addition of new Software for HPLC in QC Lab | In-progress | | | N/A | | | 14/11/2024 16:51:26 | | Zafran Meer | |
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| RA-0052-24 | 14/11/2024 | QA | Risk associated with Installation of automatic bottle counter on liquid filling line. | In-progress | | | N/A | | | 14/11/2024 16:52:42 | | Zafran Meer | |
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| RA-0053-24 | 20/11/2024 | PD | To identify the risk associated with Change in formulation of K-1000 chewable tablet | Medium | Low | Process validation will be performed | N/A | | accepted | 20/11/2024 09:02:03 | | Zafran Meer | |
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| RA-0054-24 | 21/11/2024 | QC- Packaging | To identify the risk associated with Artwork Revision | | | | N/A | | | 21/11/2024 09:10:16 | | Zafran Meer | |
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| RA-0055-24 | 09/12/2024 | Quality Assurance | Risk associated with Contamination and cross contamination | In-progress | | | N/A | | | 09/12/2024 15:01:45 | | Zafran Meer | |
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| RA-0056-24 | 09/12/2024 | Quality Assurance | Risk associated with Nitrosamine contamination in Products | In-progress | | | N/A | | | 09/12/2024 15:02:17 | | Zafran Meer | |
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| RA-0057-24 | 09/12/2024 | Quality Assurance | Risk associated with the Qualification of Supplier | In-progress | | | N/A | | | 09/12/2024 15:02:58 | | Zafran Meer | |
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| RA-0058-24 | 10/12/2024 | PD | To identify the risk associated with increase in batch size of Scifix Suspension and change in manufacturing method of evofix, scifix & cezox suspension | In-progress | | | N/A | | | 10/12/2024 13:31:35 | | Zafran Meer | |
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| RA-0059-24 | 16/12/2024 | PD | Risk associated with Change in formulation and revised artwork of Femova Sachet. | In-progress | | | N/A | | | 16/12/2024 08:57:24 | | Zafran Meer | |
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| RA-0060-24 | 16/12/2024 | PD | Risk associated with New Launch product of Linagliptin/Metformin HCl XR Tablet 2.5/1000mg & 5mg/1000mg Tablet.
| In-progress | | | N/A | | | 16/12/2024 08:59:11 | | Zafran Meer | |
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| RA-0061-24 | 16/12/2024 | QA | Risk associated with the duration and nature of the break that may affect the homogeneity of the batch. | In-progress | | | N/A | | | 16/12/2024 10:23:13 | | Zafran Meer | |
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| RA-0062-24 | 16/12/2024 | QA | Risk associated with the impact of primary and secondary packaging process on finished product | In-progress | | | N/A | | | 16/12/2024 10:24:16 | | Zafran Meer | |
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| RA-0063-24 | 16/12/2024 | Micro | Risk associated with the periodic microbial testing of finished product | In-progress | | | N/A | | | 16/12/2024 10:25:29 | | Zafran Meer | |
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| RA-0064-24 | 16/12/2024 | QC | Risk associated with the impurity testing of finished products | In-progress | | | N/A | | | 16/12/2024 10:26:31 | | Zafran Meer | |