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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 | In-progress | Accepted | 09/01/2025 08:46:04 | 21/04/2025 20:00:51 | Zafran Meer | Shaikh Muhammad Hamza Azam |
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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 | 29/01/2025 17:29:43 | 19/04/2025 12:59:53 | Hamza Ahmed | Hamza Ahmed |
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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) Process validation will be performed.
2) Stability will be charged on PV batches. | 31/12/2025 | 1) Process validation has been completed. | Accepted | 29/01/2025 17:29:57 | 19/04/2025 13:35:39 | Hamza Ahmed | Hamza Ahmed |
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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 | | Accepted | 04/02/2025 17:44:57 | 19/04/2025 13:51:02 | Hamza Ahmed | Hamza Ahmed |
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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 | | Accepted | 04/02/2025 17:47:23 | 19/04/2025 13:55:46 | Hamza Ahmed | Hamza Ahmed |
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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 | 1) Done | Accepted | 04/02/2025 17:48:57 | 27/06/2025 10:00:32 | Hamza Ahmed | Shaikh Muhammad Hamza Azam |
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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 | 1) Done | Accepted | 26/02/2025 11:05:45 | 21/05/2025 08:37:37 | Hamza Ahmed | Shaikh Muhammad Hamza Azam |
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| RA-0008-25 | 30/01/2025 | BD | Risk associated with management of artwork through software "Manage Artwork" | | | | N/A | | Accepted | 26/02/2025 11:06:11 | 19/05/2025 10:54:18 | Hamza Ahmed | Shaikh Muhammad Hamza Azam |
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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 | | Accepted | 19/04/2025 15:40:40 | 13/05/2025 11:21:20 | Hamza Ahmed | Shaikh Muhammad Hamza Azam |
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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) Cleaning method development and Cleanability studies will be performed.
2)Training will be provided on technology transfer and risk assessment to concerned staff.
3) Process validation will be performed.
4) Stability will be charged on the process validation batches.
5) Impurities need to be procured | 31/12/2026 | | Accepted | 19/04/2025 15:48:08 | 23/04/2025 08:19:47 | Hamza Ahmed | Shaikh Muhammad Hamza Azam |
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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 | | Accepted | 19/04/2025 15:57:20 | 07/05/2025 12:11:29 | Hamza Ahmed | Shaikh Muhammad Hamza Azam |
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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 | | Accepted | 19/04/2025 16:07:25 | 27/06/2025 09:37:47 | Hamza Ahmed | Shaikh Muhammad Hamza Azam |
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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 | 19/04/2025 16:11:08 | | Hamza Ahmed | |
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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 | 29/04/2025 09:55:56 | 15/05/2025 09:38:37 | Shaikh Muhammad Hamza Azam | Shaikh Muhammad Hamza Azam |
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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 | 07/05/2025 12:22:52 | 14/05/2025 14:52:47 | Shaikh Muhammad Hamza Azam | Shaikh Muhammad Hamza Azam |
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| RA-0016-25 | 02/05/2025 | Production | Risk associated with the sorting of lowplat plus 75 mg B#5C100. | In-progress | | | N/A | | | 07/05/2025 12:27:33 | 02/06/2025 13:02:28 | Shaikh Muhammad Hamza Azam | Shaikh Muhammad Hamza Azam |
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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 | 6) Done | Accepted | 07/05/2025 12:28:45 | 27/06/2025 16:27:05 | Shaikh Muhammad Hamza Azam | |
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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 | In-progress | | | N/A | | | 14/05/2025 08:46:46 | 30/06/2025 08:05:12 | Shaikh Muhammad Hamza Azam | Shaikh Muhammad Hamza Azam |
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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 | 14/05/2025 10:58:35 | 30/06/2025 08:08:23 | Shaikh Muhammad Hamza Azam | Shaikh Muhammad Hamza Azam |
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| RA-0020-25 | 14/05/2025 | QC | Risk associated with skip testing of shevit tablet | In-progress | | | N/A | | | 02/06/2025 13:06:55 | 30/06/2025 08:12:09 | Shaikh Muhammad Hamza Azam | Shaikh Muhammad Hamza Azam |
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| RA-0021-25 | 16/05/2025 | PD | Risk Associated with change in formulation of Inosita 25mg, 50mg & 100mg tablets | In-progress | | | N/A | | | 20/06/2025 09:33:15 | 30/06/2025 08:14:06 | Shaikh Muhammad Hamza Azam | Shaikh Muhammad Hamza Azam |
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| RA-0022-25 | 27/05/2025 | Production | Risk Associated with reworking of Xcept 15mg tablet | In-progress | | | N/A | | | 30/06/2025 07:57:12 | 30/06/2025 08:22:10 | Shaikh Muhammad Hamza Azam | Shaikh Muhammad Hamza Azam |
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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. | In-progress | | | N/A | | | 30/06/2025 08:25:25 | | Shaikh Muhammad Hamza Azam | |
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| RA-0024-25 | 04/06/2025 | Production | Risk associated with less than 90% compression tooling | In-progress | | | N/A | | | 30/06/2025 08:26:55 | | Shaikh Muhammad Hamza Azam | |
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| RA-0025-25 | 10/06/2025 | SCM | Risk associated with induction of alternate source of Zinc Sulfate | In-progress | | | N/A | | | 30/06/2025 08:28:40 | | Shaikh Muhammad Hamza Azam | |
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| RA-0026-25 | 13/06/2025 | QA | Risk associated with nitrosamine contamination in products | In-progress | | | N/A | | | 30/06/2025 08:30:34 | | Shaikh Muhammad Hamza Azam | |
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| RA-0027-25 | 17/06/2025 | PD | Risk associated with new launch of Vericiguat 10mg ,5mg and 2.5mg tablet | In-progress | | | N/A | | | 30/06/2025 08:33:17 | | Shaikh Muhammad Hamza Azam | |