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| RA-0001-25 | 03/01/2025 | Engineering & Validation | To identify the risk associated with the Water System and to assess the failure mode, determine the effects of failure modes, determine the severity of the effects, determine the likelihood of occurrence, calculate the Risk Priority Number (RPN), identify and prioritize corrective actions, and provide recommendations for mitigating the risks identified. | medium | low | Monthly trending will be performed | 31/05/2025 | Completed | Accepted | Zafran Meer | 03/01/2025 00:00:00 | Shaikh Muhammad Hamza Azam | 14/07/2025 11:37:51 |
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| RA-0002-25 | 20/01/2025 | Production | Risk associated with permit/allow of filling/blistering and packing of Sachet, Syrup, Tablet and Capsule on the basis of physical testing conducted by QA. | Medium | Low | 1) 1. SOP of “Release of semi - finished products for filling /Blistering and packing” will be developed. | 31/01/2025 | Completed | Accepted | Hamza Ahmed | 20/01/2025 00:00:00 | Hamza Ahmed | 19/04/2025 12:59:53 |
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| RA-0003-25 | 20/01/2025 | PD | Increased in batch size and change in manufacturing method of Evorox suspension. | Medium | Low | 1) Complete documents of trials to be provided.
2) Batch documents of evorox and evodoxime will be revised.
3) Process validation will be performed.
4) Stability will be charged on PV batches. | 31/12/2025 | In-progress | Accepted | Hamza Ahmed | 20/01/2025 00:00:00 | Shaikh Muhammad Hamza Azam | 14/07/2025 11:38:31 |
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| RA-0004-25 | 20/01/2025 | PD | To identify the risk associated with New launch product New launch product Fluticasone Furoate/ Umeclidinium/ Vilanterol 200/62.5/25mcg & 100/62.5/25mcg DPI capsule.. | High | Low | 1) ADE/PDE will be procured and containment approached will be performed.
2) Cleaning method development and Cleanability studies will be performed.
3) Training will be provided on technology transfer and risk assessment to concerned staff.
4) Process & cleaning validation will be performed.
5) Alternate source of APIs will be developed.
6) Ensure Return ducts filters for steroidal and non-steroidal drugs to be separate.
7) QC to arrange reference standards and impurities before commercialization.
8) Ensure HPMC shell color not matches with already commercialized DPI products.
| 31/12/2026 | Closed without implementation | Accepted | Hamza Ahmed | 20/01/2025 00:00:00 | Shaikh Muhammad Hamza Azam | 13/11/2025 08:07:53 |
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| RA-0005-25 | 20/01/2025 | PD | To identify the risk associated with New launch product Indacaterol/ Glycopyrronium/ Mometasone Furoate 150/50/160mcg DPI capsule. | High | Low | 1) ADE/PDE will be procured and containment approached will be performed. 2) Cleaning method development and Cleanability studies will be performed. 3) Training will be provided on technology transfer and risk assessment to concerned staff. 4) Process & cleaning validation will be performed. 5) Alternate source of APIs will be developed. 6) Ensure Return ducts filters for steroidal and non-steroidal drugs to be separate. 7) QC to arrange reference standards and impurities before commercialization. 8) Ensure HPMC shell color not matches with already commercialized DPI products. | 31/12/2026 | In-progress | Accepted | Hamza Ahmed | 20/01/2025 00:00:00 | Shaikh Muhammad Hamza Azam | 14/07/2025 11:39:05 |
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| RA-0006-25 | 22/01/2025 | PD | Risk associated with the change in formulation of Lowplat 75mg Tablet | Medium | Low | 1) Ethyl Cellulose(Ethocel ID36399) will be procured.
2) Process validation will be performed.
3) Stability will be charged on the process validation batches. | 31/05/2026 | In-progress | Accepted | Hamza Ahmed | 22/01/2025 00:00:00 | Shaikh Muhammad Hamza Azam | 14/07/2025 11:39:22 |
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| RA-0007-25 | 30/01/2025 | Engineering | Risk associated with replacement of existing dehumidifiers with new dehumidifiers in AHUs, Replacement of AHU & Installation of new ducts in production area | Medium | Low | 1) Main Corridor will be installed with a cordon-off in-front of compression cubicle 1 & 2.
2) Area Qualification. | 30/06/2025 | Completed | Accepted | Hamza Ahmed | 30/01/2025 00:00:00 | Shaikh Muhammad Hamza Azam | 14/07/2025 11:49:55 |
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| RA-0008-25 | 30/01/2025 | BD | Risk associated with management of artwork through software "Manage Artwork" | Medium | Low | 1)SOP for software Manage artwork will be developed.
2) IQ, OQ & PQ will be performed.
3) Training will be provided | 31/05/2025 | Completed | Accepted | Hamza Ahmed | 30/01/2025 00:00:00 | Shaikh Muhammad Hamza Azam | 17/07/2025 07:47:15 |
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| RA-0009-25 | 14/02/2025 | PD | Risk associated with new launch product Naproxen / Esomeprazole 500mg/20mg Tablet. | Medium | Low | 1) Training will be provided on technology transfer and risk assessment to concerned staff.
2) Containment approach to be performed.
3) Cleanability studies to be performed.
4) Process Validation will be performed.
5) Alternate source of naproxen and esomeprazole will be developed
6) Impurities need to be procured | 31/12/2026 | In-progress | Accepted | Hamza Ahmed | 14/02/2025 00:00:00 | Shaikh Muhammad Hamza Azam | 14/07/2025 11:39:55 |
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| RA-0010-25 | 14/02/2025 | PD | Risk associated with new launch product Pregablin CR 330mg , 165mg and 82.5mg Tablet. | Medium | Low | 1)Evaluation form for containment approach for new product/molecule will be provided.
2)Cleanability will be provided.
3) Training will be provided on technology transfer and risk assessment to concern staff.
4) Process validation will be performed. | 31/03/2026 | In-progress | Accepted | Hamza Ahmed | 14/02/2025 00:00:00 | Shaikh Muhammad Hamza Azam | 14/07/2025 11:40:14 |
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| RA-0011-25 | 06/03/2025 | SCM | Risk Associated with the induction of new source induction of raw materials
| Medium | Low | 1) Procedure will be developed for intimation and quantities required for process validation of new source | 30/06/2025 | Extension in timeline till 31/12/2025 | Accepted | Hamza Ahmed | 06/03/2025 00:00:00 | Shaikh Muhammad Hamza Azam | 14/07/2025 11:41:45 |
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| RA-0012-25 | 12/03/2025 | PD | Risk associated with new launch product Roxadustat 70mg, 100mg, 150mg Tablet. | Medium | Low | 1) Evaluation form of containment approach
for new product/molecule will be provided.
2) Cleanability will be performed.
3) Training will be provided on technology transfer and risk assessment to concerned staff. 4) Process validation will be performed.
5) Alternate source of Roxadustat will be developed. | 31/12/2026 | In-progress | Accepted | Hamza Ahmed | 12/03/2025 00:00:00 | Shaikh Muhammad Hamza Azam | 14/07/2025 11:42:36 |
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| RA-0013-25 | 04/04/2025 | Warehouse | Title of Risk Dispensing Operation and Transfer of Dispensed Batches from Dispensing to WIP Production (Non Ceph). | N/A | N/A | N/A | N/A | N/A | Accepted | Hamza Ahmed | 04/04/2025 00:00:00 | | |
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| RA-0014-25 | 29/04/2025 | Production | Risk associated with reworking of Eglaro-S tablet | Medium | Low | 1. Chemical testing on core tablet and chemical & microbial testing on coated tablet will be performed.
2.Batch will be charge on the stability and results will be critically monitored after each interval at both (accelerated and long term till self life) | 28/02/2027 | In-progress | Accepted | Shaikh Muhammad Hamza Azam | 29/04/2025 09:55:56 | Shaikh Muhammad Hamza Azam | 15/05/2025 09:38:37 |
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| RA-0015-25 | 29/04/2025 | PD | New launch product Kalsob-M sachet. | Medium | Low | 1. Training will be provided on technology transfer and risk assessment to concerned staff.
2. Process validation will be performed
3. Alternate source of Red algae calcium will be developed.
4. Halal certification of Kalsob-M Sachet will be arranged.
5. Complete stability report will be shared.
6. PV batches will be charge on stability | 30/08/2027 | In-progress | Accepted | Shaikh Muhammad Hamza Azam | 29/04/2025 00:00:00 | Shaikh Muhammad Hamza Azam | 14/05/2025 14:52:47 |
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| RA-0016-25 | 02/05/2025 | Production | Risk associated with capping in tablet of lowplat plus 75 mg B#5C100. | Medium | Low | 1.Machine will be handed over to the engineering department.
2.No further batches will be processed on the machine until it is confirmed to be functioning properly | 31/05/2025 | Completed | Accepted | Shaikh Muhammad Hamza Azam | 02/05/2025 00:00:00 | Shaikh Muhammad Hamza Azam | 14/07/2025 11:50:58 |
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| RA-0017-25 | 07/05/2025 | PD | New launch product vibegron 75mg Tablet | Medium | Low | 1.Containmnet approach to be performed
2.Cleanability studies to be performed
3.Traning will be provided on technology transfer and risk assessment to concern staff
4.Process validation will be performed
5.Alternate source of Vibegron will be developed
6.Vendor proton pharma solution Ltd. will be qualified
7.Impurities will be procured | 30/09/2026 | In-progress | Accepted | Shaikh Muhammad Hamza Azam | 07/05/2025 12:28:45 | Shaikh Muhammad Hamza Azam | 14/07/2025 11:42:05 |
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| RA-0018-25 | 07/05/2025 | PD | Risk associated with change in formulation of Dapwiz plus XR 5/1000mg & 10/1000mg Tablet | Medium | Low | 1.Trial batch document of PD batches to be submitted along with the initial analytical results.
2.Analytical method specification will be revised.
3.BDR and BMR to be updated.
4.BOM will be revised
5.Process Validation will be performed.
6.Stability will be performed
7.Variation will be submitted in regulatory bodies
| 28/02/2026 | In-progress | Accepted | Shaikh Muhammad Hamza Azam | 07/05/2025 00:00:00 | Shaikh Muhammad Hamza Azam | 14/07/2025 11:51:33 |
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| RA-0019-25 | 14/05/2025 | Production | Risk associated with dispensing of raw materials | Low | N/A | N/A | N/A | N/A | Accepted | Shaikh Muhammad Hamza Azam | 14/05/2025 10:58:35 | Shaikh Muhammad Hamza Azam | 30/06/2025 08:08:23 |
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| RA-0020-25 | 14/05/2025 | QC | Risk associated with skip testing of shevit tablet | Medium | Low | 1. Specification of shevit tablet will be revised
2. SOP QCG/2/016 will be revised to incorporate clause of annual stability testing of shevit tablet | 31/07/2025 | In-progress | Accepted | Shaikh Muhammad Hamza Azam | 14/05/2025 00:00:00 | Shaikh Muhammad Hamza Azam | 05/07/2025 14:36:33 |
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| RA-0021-25 | 16/05/2025 | PD | Risk Associated with change in formulation of Inosita 25mg, 50mg & 100mg tablets | Medium | Low | 1.BOM will be updated in SAP
2.BDR and BMR will be revised for Inosita 25mg. Inosita 50mg & Inosita 100mg tablet
3.Process Validation will be performed
4.One batch of each strength (i.e: inosita 25mg, Inosita 50mg & Inosita 100mg tablet) will be charge on stability.
5.Variation will be submitted in regulatory bodies | 31/12/2025 | In-Progress | Accepted | Shaikh Muhammad Hamza Azam | 16/05/2025 00:00:00 | Shaikh Muhammad Hamza Azam | 05/07/2025 15:27:13 |
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| RA-0022-25 | 27/05/2025 | Production | Risk Associated with reworking of Xcept 15mg tablet | Medium | Low | 1.Reprocessing BMR will be issued as per reprocessing form.
2.Additional material will be issued from warehouse as per reprocessing form
3.Sample for chemical testing will be submitted to QC after compression.
4.Sample for chemical and microbial testing will be submitted to QC after coating
5.Batch will be charge on the stability and results will critically monitor after each interval. | 31/08/2025 | In-progress | Accepted | Shaikh Muhammad Hamza Azam | 27/05/2025 00:00:00 | Shaikh Muhammad Hamza Azam | 05/07/2025 19:56:05 |
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| RA-0023-25 | 27/05/2025 | SCM | Risk assessment for the procurement of materials from Indian manufacturers (Source) due to current geo-political situation between India and Pakistan. | Medium | Low | 1.Alternate source of materials will be developed as per attached list
2.SOP will be developed in which complete procedure will be defined including receiving of materials, testing of raw materials, validation, stability and other requirement for the conditionally approved sources
3.Interim approved vendor list for materials mentioned in attached list will be developed for conditionally approved sources | 31/12/2025 | In-progress | Accepted | Shaikh Muhammad Hamza Azam | 27/05/2025 00:00:00 | Shaikh Muhammad Hamza Azam | 17/07/2025 07:49:33 |
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| RA-0024-25 | 04/06/2025 | Production | Risk associated with less than 90% compression tooling | Medium | Low | 1. SOP PMG/5/049 will be revised to incorporate tolerance limit of tooling wear that is permissible to keep tools in service
2. List of available inventory of tooling will be prepared.
3. Backup inventory of tooling will be procured as per the requirement
| 30/06/2026 | In-progress | Accepted | Shaikh Muhammad Hamza Azam | 04/06/2025 00:00:00 | Shaikh Muhammad Hamza Azam | 15/07/2025 09:30:10 |
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| RA-0025-25 | 10/06/2025 | SCM | Risk associated with induction of alternate source of Zinc Sulfate | Medium | Low | 1.COA will be reviewed and samples will be tested according to approved specification.
2.Vendor will be approved and added in approved vendor list
3.Process validation will be performed on three commercial batches
4.Stability will be charged on both long term and accelerated conditions
5.intimation will be sent to WHO for change in source of API (zinc sulfate)
| 31/10/2025 | In-progress | Accepted | Shaikh Muhammad Hamza Azam | 10/06/2025 00:00:00 | Shaikh Muhammad Hamza Azam | 13/11/2025 08:46:58 |
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| RA-0026-25 | 17/06/2025 | QA | Risk associated with new launch of Vericiguat 10mg ,5mg and 2.5mg tablet | high | Low | 1. Evaluation Form for containment Approach for New Product/Molecule will be provided.
2. Cleanability will be provided.
3. Training will be provided on technology transfer and risk assessment to concerned staff.
4. Process validation will be performed
5. Alternate source of vericiguat will be developed.
| 31/07/2026 | In-progress | Accepted | Shaikh Muhammad Hamza Azam | 17/06/2025 00:00:00 | Shaikh Muhammad Hamza Azam | 15/07/2025 12:20:18 |
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| RA-0027-25 | 30/06/2025 | PD | Risk associated with nitrosamine contaimination in products | High | Low | 1. Nitrosamines declaration from API and excipients vendors will be arranged.
2. Nitrosamines testing will be performed on selective batches
3. SOP of supplier qualification QAG/2/037 will be revised to incorporate nitrosamine declaration in required document list from vendor | 31/12/2026 | In-progress | Accepted | Shaikh Muhammad Hamza Azam | 30/06/2025 08:33:17 | Shaikh Muhammad Hamza Azam | 13/11/2025 08:49:08 |
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| RA-0028-25 | 03/07/2025 | PD | Risk associated with change in formulation of Byvas 10mg, 5mg and 2.5mg tablet to improve similarity factor in Comparative dissolution profile (CDP). | Medium | Low | 1. Trial batch document of PD batches to be submitted along with the initial analytical results and stability results.
2. SAP BOM will be updated for Byvas 2.5mg. 5mg and 10mg tablet
3. Process Validation will be performed on all three strengths of Byvas tablet 2.5mg, 5mg and 10mg as per matrixing approach.
4. Analytical method specification will be revised for all three strengths of Byvas tablet 2.5mg, 5mg and 10mg and updated in LIMS.
5. BDR and BMR to be updated for all three strengths of Byvas tablet 2.5mg, 5mg and 10mg.
6. Stability will be conducted on all three strengths of Byvas tablet 2.5mg, 5mg and 10mg
| 31/03/2026 | In-progress | Accepted | Shaikh Muhammad Hamza Azam | 03/07/2025 00:00:00 | Shaikh Muhammad Hamza Azam | 15/07/2025 11:47:12 |
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| RA-0029-25 | 03/07/2025 | PD | Risk associated with Change in formulation of Gouric 80mg and 40mg tablet to improve similarity factor in Comparative dissolution profile (CDP). | Medium | Low | 1.Trial batch document of PD batches will be submitted along with the initial analytical results.
2.DMV documents will be submitted.
3.Analytical method specification will be revised to update Dissolution method as per FDA and average weight of tablet for both strengths of Gouric 40mg and 80mg.
4.BDR, BMR, BPR and BOM to be revised for both strengths of Gouric 40mg & 80mg.
5.New art work will be design
6.New Codes of packaging material will be open in SAP
7.Procurement of new packaging material
8.Production to procure new punches as per trial batch.
9.Backup inventory of tooling will be checked
10.Process Validation will be performed on both strengths of Gouric tablet Moreover, hold time study will also be performed.
11.Stability studies will be conducted
12.Variation will be submitted as per requirement in export.
| 30/09/2026 | In-progress | Accepted | Shaikh Muhammad Hamza Azam | 03/07/2025 00:00:00 | Shaikh Muhammad Hamza Azam | 13/11/2025 11:20:31 |
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| RA-0030-25 | 31/07/2025 | PD | Risk associated with change in formulation of Sacvin 200mg, 100mg and 50mg Tablet to reduce tablet weight in accordance with innovator tablets. | High | Low | 1. Six months stability results of trial batch will be submitted for all three strengths of Sacvin tablet range
2.Analytical method specification will be revised for thickness and average weight for all three strengths of Sacvin tablet range
3.BDR, BMR, BPR and BOM to be revised for all strengths of Sacvin Tablet Range
4.New art work will be design for all three strength of Sacvin tablet range
5.New Codes of packaging material will be open in SAP
6.Procurement of new packaging material
7.Process Validation will be performed on all strengths of Sacvin Tablet Range. Moreover, hold time study will also be performed.
8.Stability studies will be conducted
9.Variation will be submitted as per requirement in export.
| 30/09/2026 | In-progress | Accepted | Shaikh Muhammad Hamza Azam | 31/07/2025 08:29:12 | Shaikh Muhammad Hamza Azam | 13/11/2025 11:21:13 |
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| RA-0031-25 | 31/07/2025 | QA | Risk associated with the cleaning validation of insoluble API’s | Medium | Low | 1. Identification of worst-case products on basis of equipment
2. MACO will be calculated with three approaches (10ppm, HBEL & ADE/PDE)
3. Identification of minimum safety limit
4. Analytical method validation will be performed against minimum safety limit
5. Three consecutive batches will be taken for cleaning validation
6. DEHT and CEHT will be performed on worst-case products
7. Procedure for cleaning validation will be revised
8.procedure for analytical method validation will be prepared.
9. Detergent will be qualified | 30/06/2026 | In-progress | Accepted | Shaikh Muhammad Hamza Azam | 06/08/2025 09:56:51 | Shaikh Muhammad Hamza Azam | 12/11/2025 17:15:59 |
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| RA-0032-25 | 01/08/2025 | QA | Risk associated with BDR software | Medium | Low | 1. Software will be developed as per URS
2. SOP for issuance of BDR trough BDR Software will be developed.
3. IQ, OQ & PQ will be performed.
4. Training will be provided.
| 31/03/2026 | In-progress | Accepted | Shaikh Muhammad Hamza Azam | 12/08/2025 10:29:14 | Shaikh Muhammad Hamza Azam | 11/11/2025 15:24:37 |
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| RA-0033-25 | 08/08/2025 | BD | Risk associated with Toll/contract manufacturing of products | Low | N/A | N/A | N/A | N/A | Accepted | Shaikh Muhammad Hamza Azam | 11/09/2025 15:24:34 | Shaikh Muhammad Hamza Azam | 13/11/2025 08:44:20 |
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| RA-0034-25 | 13/08/2025 | SCM | Risk associated with source development and approval through online software-based system | Medium | Low | 1. SOP for source development and approval through online software-based system will be developed.
2. IQ, OQ & PQ will be performed.
3. Training will be provided.
| 31/12/2025 | In-progress | Accepted | Shaikh Muhammad Hamza Azam | 12/09/2025 08:28:14 | Shaikh Muhammad Hamza Azam | 11/11/2025 15:26:31 |
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| RA-0035-25 | 15/08/2025 | QC | Risk associated with anti-microbial resistance | Low | N/A | N/A | N/A | N/A | Accepted | Shaikh Muhammad Hamza Azam | 12/09/2025 08:30:41 | Shaikh Muhammad Hamza Azam | 13/11/2025 11:16:53 |
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| RA-0036-25 | 21/08/2025 | PD | Change in formulation of Oxivort 10mg tablet | Medium | Low | | 31/08/2026 | In-progress | Accepted | Shaikh Muhammad Hamza Azam | 12/09/2025 08:32:11 | Shaikh Muhammad Hamza Azam | 13/11/2025 11:19:38 |
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| RA-0037-25 | 29/08/2025 | PD | Risk associated with change in coating material of products (list attached) | Medium | Low | 1. SAP BOM will be revised for all products mentioned in annexure-1.
2. BDR and BMR will be revised for all products mentioned in annexure-1.
3. Coating spray rate must be greater than or equal to 15Hzin BMR
4. Process validation and hold time study will be performed for all products mentioned in annexure-1.
5. Stability studies need to be conducted for all products mentioned in annexure-1
6. Stability studies will be conducted
7. Variation will be submitted as per requirement in export.
| 31/12/2026 | In-progress | Accepted | Shaikh Muhammad Hamza Azam | 12/09/2025 10:26:16 | Shaikh Muhammad Hamza Azam | 13/11/2025 08:28:35 |
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| RA-0038-25 | 03/09/2025 | PD | Risk associated with change in formulation of Zi-AD tablet as per WHO expression of interest. | Medium | Low
| 1. Trial will be performed
2. Stability studies will be conducted on trial batch
3. BMR, BDR, BPR, BYS and BOM will be prepared
4. Artwork according to new label claim will be developed
5. Blister tooling will be developed as per hoonga machine.
6. New codes for packaging material will be opened & packaging material will be procured
7. Process Validation & HTS will be performed
8. Cleaning Validation will be performed on blistering stage
9. Method verification will be performed
10. Finished product testing method & SAP plans will be developed
11. Testing method for packaging component & SAP plan will be developed
12. Stability will be charge on three commercial batches.
13. Dossier will be submitted | 30/06/2026 | In-progress | Accepted | Shaikh Muhammad Hamza Azam | 22/09/2025 08:18:42 | Shaikh Muhammad Hamza Azam | 12/11/2025 16:45:34 |
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| RA-0039-25 | 03/09/2025 | PD | Risk associated with change in formulation of Zi-AD syrup as per WHO expression of interest | Medium | Low | 1.Trial will be performed
2. Stability studies will be conducted on trial batch
3. BMR, BDR, BPR, BYS and BOM will be prepared
4. Artwork according to new label claim will be developed
5. New codes for packaging material will be opened & packaging material will be procured
7. Process Validation & HTS will be performed
8. Cleaning Validation will be performed on blistering stage
9. Method verification will be performed
10. Finished product testing method & SAP plans will be developed
11. Testing method for packaging component & SAP plan will be developed 12. Stability will be charge on three commercial batches. 13. Dossier will be submitted | 30/06/2026 | In-progress | Accepted | Shaikh Muhammad Hamza Azam | 22/09/2025 08:19:30 | Shaikh Muhammad Hamza Azam | 13/11/2025 08:33:16 |
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| RA-0040-25 | 04/09/2025 | QC | Risk associated with increase in validity of working standard as per attached list | Medium | Low | 1. Lot selected for standardization will be compared with commercial lot and results must not exceed 2% criteria. Clause will be added in SOP. Moreover, list of materials will be added in SOP for standardization of working standard (QCG/2/015).
2. Procedure for supply chain traceability will be incorporated for primary reference standards procurement
3. Training will be provided to concern staff of QC.
| 31/01/2026 | In-progress | Accepted | Shaikh Muhammad Hamza Azam | 22/09/2025 08:38:22 | Shaikh Muhammad Hamza Azam | 11/11/2025 15:29:25 |
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| RA-0041-25 | 17/09/2025 | Production/warehouse | Revamping existing 40ft packaging WH and a part of Pharma Mfg. area | Medium | Low | 1. Area layout will be revised
2. Qualification and requalification of areas will be performed
3. URS of machines will be prepared
4. Machines will be qualified
5.SOPs will be prepared
6.SMF will be updated
7. Facility maintenance plan will be revised
8. New machines will be added in preventive maintenance plan | 31/12/2026 | In-progress | Accepted | Shaikh Muhammad Hamza Azam | 22/09/2025 08:39:44 | Shaikh Muhammad Hamza Azam | 13/11/2025 13:02:58 |
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| RA-0042-25 | 23/09/2025 | Production | Risk associated with the reworking of Inosita Plus XR | Medium | Low | 1. BMRs will be issued as per reworking and reprocessing request form QAG/5/111
2. Additional quantity of API will be issued as per reworking and reprocessing request forms QAG/5/111
3. Testing will be performed after API coating, upon satisfactory results batch will then be proceeded for film coating
4. Batches will be charge on the stability and results will critically monitor after each interval.
| 30/11/2025 | In-progress | Accepted | Hamza Ahmed | 23/09/2025 15:00:38 | Shaikh Muhammad Hamza Azam | 11/11/2025 15:32:30 |
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| RA-0043-25 | 26/09/2025 | QC | Risk associated with installation of cool incubator in QC micro Non-ceph (General Pharma QC lab) | Medium |
Low | 1)Qualification will be performed. (QA-val)
2)Equipment will be added in calibration list QCG/3/001 (QC)
3)SOP will be prepared and training will be provided (QC Micro) | 31/12/2025 | In-progress | | Shaikh Muhammad Hamza Azam | 01/10/2025 08:39:01 | Shaikh Muhammad Hamza Azam | 13/11/2025 09:21:59 |
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| RA-0044-25 | 26/09/2025 | Production | Risk associated with addition of ZP23D compression machine in nutra facility | Medium | Low | 1.Cleaning Verification will be performed
2. Qualification of ZP23D compression machine
3. Tooling will be procured for Kalsob Tablet
4. Process validation of Kalsob will be performed
5. Machine will be added in preventive maintenance plan
6. SOP and logbook will be prepared
7.Batch document will be revised to add ZP23D compression machine
8.batch will be charge on stability | 30/06/2026 | In-progress | Accepted | Shaikh Muhammad Hamza Azam | 01/10/2025 08:41:55 | Shaikh Muhammad Hamza Azam | 13/11/2025 14:48:53 |
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| RA-0045-25 | 26/09/2025 | QC | Risk associated with launch of new product in export | Low | N/A | N/A | N/A | N/A | Accepted | Shaikh Muhammad Hamza Azam | 09/10/2025 16:00:27 | Shaikh Muhammad Hamza Azam | 13/11/2025 09:17:14 |
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| RA-0046-25 | 06/10/2025 | Production | Risk associated with Revamping of QC (General pharma) | Medium | Low | 1. Area Layout will be prepared | 31/03/2026 | In-progress | Accepted | Shaikh Muhammad Hamza Azam | 09/10/2025 16:04:08 | Shaikh Muhammad Hamza Azam | 13/11/2025 09:04:27 |
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| RA-0047-25 | 30/06/2025 | QA | Potential of Nitrosamine impurity in attached list of products | High | Low | 1. Nitrosamines declaration from API and excipients vendors will be arranged.
2. Nitrosamines testing will be performed on selective batches
3. SOP of supplier qualification QAG/2/037 will be revised to incorporate nitrosamine declaration in required document list from vendor
| 31/12/2025 | In-progress | Accepted | Shaikh Muhammad Hamza Azam | 10/10/2025 12:13:43 | Shaikh Muhammad Hamza Azam | 13/11/2025 09:43:13 |
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| RA-0048-25 | 10/10/2025 | QA | Risk associated with optical inspection of aseptically filled cephalosporin sterile products | Medium | Low | 1. SOP QAG/2/002 will be revised to incorporate the sample collection, transfer of samples to optical room, reconstitution of vials, rejection of optical inspected sterile vials of cephalosporin area.
2. Training on revised SOP will be delivered.
3. Change control will be initiated for yield limits revision.
| 31/12/2025 | In-progress | Accepted | Shaikh Muhammad Hamza Azam | 10/10/2025 12:14:07 | Shaikh Muhammad Hamza Azam | 11/11/2025 15:35:40 |
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| RA-0049-25 | 16/10/2025 | QA | Risk assessment for aggregation system for pharmaceutical product serialization | Medium | Low | 1. Printers will be installed
2. qualification of aggregation system will be performed
3. Aggregation system will be integrated with SAP
4. Validation will be performed | 31/03/2026 | In-progress | Accepted | Shaikh Muhammad Hamza Azam | 22/10/2025 08:18:36 | Shaikh Muhammad Hamza Azam | 13/11/2025 15:14:55 |
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| RA-0050-25 | 16/10/2025 | BD | Risk associated with new launch of products OPT-D 5000IU & 10000IU | In-progress | | | N/A | | | Shaikh Muhammad Hamza Azam | 22/10/2025 08:46:48 | Shaikh Muhammad Hamza Azam | 24/10/2025 11:15:52 |
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| RA-0051-25 | 22/10/2025 | QA | Risk associated with the OSD facility | Low | N/A | N/A | N/A | N/A | N/A | Shaikh Muhammad Hamza Azam | 30/10/2025 12:32:56 | Shaikh Muhammad Hamza Azam | 13/11/2025 08:39:43 |
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| RA-0052-25 | 23/10/2025 | PD | Risk associated with new launch silodosin 4mg and 8mg capsule | Medium | Low | 1. Cleanability studies will be performed.
2. Physical appearance (color) of Empty capsule shell to be checked
3. Training will be provided on technology transfer and risk assessment to concerned staff.
4. Process validation, cleaning validation and HTS will be performed.
5. Alternate source of silodosin will be developed.
6. New codes of materials will be opened.
7. Raw material testing method and inspection plan will be prepared.
8. Finished product testing method and inspection plan will be prepared.
9. Packaging material testing method and inspection plan will be prepared.
10. Batches of both strengths will be charge on stability | 31/01/2027 | In-progress | Accepted | Shaikh Muhammad Hamza Azam | 30/10/2025 12:34:28 | Shaikh Muhammad Hamza Azam | 13/11/2025 08:37:18 |
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| RA-0053-25 | 23/10/2025 | Production | Risk associated with spillage of material in production area | Low | N/A | N/A | N/A | N/A | Accepted | Shaikh Muhammad Hamza Azam | 30/10/2025 13:03:56 | Shaikh Muhammad Hamza Azam | 13/11/2025 09:46:15 |
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| RA-0054-25 | 23/10/2025 | PD | Risk associated with new launch of Linaclotide 72mcg, 145mcg, 290mcg Capsules | In-progress | | | N/A | | | Shaikh Muhammad Hamza Azam | 30/10/2025 13:04:45 | | |
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| RA-0055-25 | 23/10/2025 | PD | Risk associated with new launch of Beclometasone/ Formoterol/ Glycopyrronium DPI 100mcg/6mcg/10mcg capsules. | In-progress | | | N/A | | | Shaikh Muhammad Hamza Azam | 30/10/2025 13:05:33 | Shaikh Muhammad Hamza Azam | 13/11/2025 13:00:09 |
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| RA-0056-25 | 24/10/2025 | QC | Risk associated with microbiological environmental monitoring of manufacturing, sampling and dispensing booths of general pharma | Medium | Low | Microbial monitoring will be done again as per area and worst cases will be identified. SOP QCM/2/033 will be revised and locations will be added in SOP | 31/12/2025 | In-progress | Accepted | Shaikh Muhammad Hamza Azam | 30/10/2025 13:13:01 | Shaikh Muhammad Hamza Azam | 13/11/2025 09:47:26 |
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| RA-0057-25 | 06/11/2025 | PD | Risk associated with new launch of brivaracetam 25mg, 50mg & 100mg tablet | In-progress | | | N/A | | | Shaikh Muhammad Hamza Azam | 06/11/2025 15:20:40 | | |
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| RA-0058-25 | 06/11/2025 | PD | Risk associated with new launch of brivaracetam 10mg/ml oral Solution | In-progress | | | N/A | | | Shaikh Muhammad Hamza Azam | 06/11/2025 15:21:03 | | |
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| RA-0059-25 | 06/11/2025 | Warehouse | Risk associated with the mix up of packaging material in warehouse. | In-progress | | | N/A | | | Shaikh Muhammad Hamza Azam | 06/11/2025 15:21:47 | | |