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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 | In-progress | Accepted | Hamza Ahmed | 20/01/2025 00:00:00 | Shaikh Muhammad Hamza Azam | 14/07/2025 11:38:50 |
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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 | 05/07/2025 21:05:06 |
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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 | | | | N/A | Risk under assessment | | Shaikh Muhammad Hamza Azam | 30/06/2025 08:33:17 | Shaikh Muhammad Hamza Azam | 15/07/2025 12:40:11 |
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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). | In-progress | | | N/A | Risk under assessment | | Shaikh Muhammad Hamza Azam | 03/07/2025 00:00:00 | Shaikh Muhammad Hamza Azam | 17/07/2025 07:47:42 |
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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. | In-progress | | | N/A | | | Shaikh Muhammad Hamza Azam | 31/07/2025 08:29:12 | | |
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| RA-0031-25 | 31/07/2025 | QA | Risk associated with the cleaning validation of insoluble API’s | In-progress | | | N/A | | | Shaikh Muhammad Hamza Azam | 06/08/2025 09:56:51 | | |
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| RA-0032-25 | 01/08/2025 | QA | Risk associated with BDR software | In-progress | | | N/A | | | Shaikh Muhammad Hamza Azam | 12/08/2025 10:29:14 | | |
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| RA-0033-25 | 08/08/2025 | RA | Risk associated with new launch of Uroease (Dutasteride+Tamsulosin) Caps 0.5mg/0.4mg thorugh contract manufacturing | In-progress | | | N/A | | | Shaikh Muhammad Hamza Azam | 11/09/2025 15:24:34 | | |
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| RA-0034-25 | 13/08/2025 | SCM | Risk associated with source development and approval through online software-based system | In-progress | | | N/A | | | Shaikh Muhammad Hamza Azam | 12/09/2025 08:28:14 | | |
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| RA-0035-25 | 15/08/2025 | QC | Risk associated with anti-microbial resistance | In-progress | | | N/A | | | Shaikh Muhammad Hamza Azam | 12/09/2025 08:30:41 | | |
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| RA-0036-25 | 21/08/2025 | PD | Change in formulation of Oxivort 10mg tablet | In-progress | | | N/A | | | Shaikh Muhammad Hamza Azam | 12/09/2025 08:32:11 | | |
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| RA-0037-25 | 29/08/2025 | PD | Risk associated with change in coating material of products (list attached) | In-progress | | | N/A | | | Shaikh Muhammad Hamza Azam | 12/09/2025 10:26:16 | | |