Ref. SOP No. QAG/2/050

PHARMEVO (PVT.) LTD.

Document No. QAG/5/126

Title: Risk Log


 
 RA NoReceiving DateRA OwnerRisk DescriptionInitial Risk LevelAfter Mitigation Risk LevelActions Plan for MitigationTimelineStatus of Action PlanRisk DecisionCreated ByCreated OnUpdated ByUpdated On
RA-0001-2503/01/2025Engineering & ValidationTo 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. mediumlowMonthly trending will be performed31/05/2025CompletedAcceptedZafran Meer03/01/2025 00:00:00Shaikh Muhammad Hamza Azam14/07/2025 11:37:51
RA-0002-2520/01/2025ProductionRisk associated with permit/allow of filling/blistering and packing of Sachet, Syrup, Tablet and Capsule on the basis of physical testing conducted by QA.MediumLow1) 1. SOP of “Release of semi - finished products for filling /Blistering and packing” will be developed.31/01/2025CompletedAcceptedHamza Ahmed 20/01/2025 00:00:00Hamza Ahmed 19/04/2025 12:59:53
RA-0003-2520/01/2025PDIncreased in batch size and change in manufacturing method of Evorox suspension.MediumLow1) 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.31/12/2025In-progressAcceptedHamza Ahmed 20/01/2025 00:00:00Shaikh Muhammad Hamza Azam14/07/2025 11:38:31
RA-0004-25 20/01/2025PDTo 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..HighLow1) 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. 31/12/2026In-progressAcceptedHamza Ahmed 20/01/2025 00:00:00Shaikh Muhammad Hamza Azam14/07/2025 11:38:50
RA-0005-25 20/01/2025PDTo identify the risk associated with New launch product Indacaterol/ Glycopyrronium/ Mometasone Furoate 150/50/160mcg DPI capsule.HighLow1) 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.31/12/2026In-progressAcceptedHamza Ahmed 20/01/2025 00:00:00Shaikh Muhammad Hamza Azam14/07/2025 11:39:05
RA-0006-2522/01/2025PD Risk associated with the change in formulation of Lowplat 75mg TabletMediumLow1) Ethyl Cellulose(Ethocel ID36399) will be procured. 2) Process validation will be performed. 3) Stability will be charged on the process validation batches.31/05/2026In-progressAcceptedHamza Ahmed 22/01/2025 00:00:00Shaikh Muhammad Hamza Azam14/07/2025 11:39:22
RA-0007-2530/01/2025EngineeringRisk associated with replacement of existing dehumidifiers with new dehumidifiers in AHUs, Replacement of AHU & Installation of new ducts in production area MediumLow1) Main Corridor will be installed with a cordon-off in-front of compression cubicle 1 & 2. 2) Area Qualification.30/06/2025CompletedAcceptedHamza Ahmed 30/01/2025 00:00:00Shaikh Muhammad Hamza Azam14/07/2025 11:49:55
RA-0008-2530/01/2025BDRisk associated with management of artwork through software "Manage Artwork"MediumLow1)SOP for software Manage artwork will be developed. 2) IQ, OQ & PQ will be performed. 3) Training will be provided31/05/2025CompletedAcceptedHamza Ahmed 30/01/2025 00:00:00Shaikh Muhammad Hamza Azam17/07/2025 07:47:15
RA-0009-2514/02/2025PDRisk associated with new launch product Naproxen / Esomeprazole 500mg/20mg Tablet.MediumLow1) 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 procured31/12/2026In-progressAcceptedHamza Ahmed 14/02/2025 00:00:00Shaikh Muhammad Hamza Azam14/07/2025 11:39:55
RA-0010-2514/02/2025PDRisk associated with new launch product Pregablin CR 330mg , 165mg and 82.5mg Tablet.MediumLow1)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.31/03/2026In-progressAcceptedHamza Ahmed 14/02/2025 00:00:00Shaikh Muhammad Hamza Azam14/07/2025 11:40:14
RA-0011-2506/03/2025SCMRisk Associated with the induction of new source induction of raw materials MediumLow1) Procedure will be developed for intimation and quantities required for process validation of new source30/06/2025Extension in timeline till 31/12/2025AcceptedHamza Ahmed 06/03/2025 00:00:00Shaikh Muhammad Hamza Azam14/07/2025 11:41:45
RA-0012-2512/03/2025PDRisk associated with new launch product Roxadustat 70mg, 100mg, 150mg Tablet.MediumLow1) 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.31/12/2026In-progressAcceptedHamza Ahmed 12/03/2025 00:00:00Shaikh Muhammad Hamza Azam14/07/2025 11:42:36
RA-0013-2504/04/2025WarehouseTitle of Risk Dispensing Operation and Transfer of Dispensed Batches from Dispensing to WIP Production (Non Ceph).N/AN/AN/AN/AN/AAcceptedHamza Ahmed 04/04/2025 00:00:00  
RA-0014-2529/04/2025ProductionRisk associated with reworking of Eglaro-S tabletMediumLow1. 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)28/02/2027In-progressAcceptedShaikh Muhammad Hamza Azam29/04/2025 09:55:56Shaikh Muhammad Hamza Azam15/05/2025 09:38:37
RA-0015-2529/04/2025PDNew launch product Kalsob-M sachet.MediumLow1. 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 stability30/08/2027In-progressAcceptedShaikh Muhammad Hamza Azam29/04/2025 00:00:00Shaikh Muhammad Hamza Azam14/05/2025 14:52:47
RA-0016-2502/05/2025ProductionRisk associated with capping in tablet of lowplat plus 75 mg B#5C100.MediumLow1.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 properly31/05/2025CompletedAcceptedShaikh Muhammad Hamza Azam02/05/2025 00:00:00Shaikh Muhammad Hamza Azam14/07/2025 11:50:58
RA-0017-2507/05/2025PDNew launch product vibegron 75mg TabletMediumLow1.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 procured30/09/2026In-progressAcceptedShaikh Muhammad Hamza Azam07/05/2025 12:28:45Shaikh Muhammad Hamza Azam14/07/2025 11:42:05
RA-0018-2507/05/2025PDRisk associated with change in formulation of Dapwiz plus XR 5/1000mg & 10/1000mg TabletMediumLow1.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 28/02/2026In-progressAcceptedShaikh Muhammad Hamza Azam07/05/2025 00:00:00Shaikh Muhammad Hamza Azam14/07/2025 11:51:33
RA-0019-2514/05/2025ProductionRisk associated with dispensing of raw materialsLowN/AN/AN/AN/AAcceptedShaikh Muhammad Hamza Azam14/05/2025 10:58:35Shaikh Muhammad Hamza Azam30/06/2025 08:08:23
RA-0020-2514/05/2025QCRisk associated with skip testing of shevit tablet MediumLow1. 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 31/07/2025In-progressAcceptedShaikh Muhammad Hamza Azam14/05/2025 00:00:00Shaikh Muhammad Hamza Azam05/07/2025 14:36:33
RA-0021-2516/05/2025PDRisk Associated with change in formulation of Inosita 25mg, 50mg & 100mg tabletsMediumLow1.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 31/12/2025In-ProgressAcceptedShaikh Muhammad Hamza Azam16/05/2025 00:00:00Shaikh Muhammad Hamza Azam05/07/2025 15:27:13
RA-0022-2527/05/2025ProductionRisk Associated with reworking of Xcept 15mg tabletMediumLow1.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.31/08/2025In-progressAcceptedShaikh Muhammad Hamza Azam27/05/2025 00:00:00Shaikh Muhammad Hamza Azam05/07/2025 19:56:05
RA-0023-2527/05/2025SCMRisk assessment for the procurement of materials from Indian manufacturers (Source) due to current geo-political situation between India and Pakistan.MediumLow1.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 sources31/12/2025In-progressAcceptedShaikh Muhammad Hamza Azam27/05/2025 00:00:00Shaikh Muhammad Hamza Azam17/07/2025 07:49:33
RA-0024-2504/06/2025ProductionRisk associated with less than 90% compression toolingMediumLow1. 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 30/06/2026In-progressAcceptedShaikh Muhammad Hamza Azam04/06/2025 00:00:00Shaikh Muhammad Hamza Azam15/07/2025 09:30:10
RA-0025-2510/06/2025SCMRisk associated with induction of alternate source of Zinc SulfateMediumLow1.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) 31/10/2025In-progressAcceptedShaikh Muhammad Hamza Azam10/06/2025 00:00:00Shaikh Muhammad Hamza Azam05/07/2025 21:05:06
RA-0026-2517/06/2025QARisk associated with new launch of Vericiguat 10mg ,5mg and 2.5mg tablethighLow1. 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. 31/07/2026In-progressAcceptedShaikh Muhammad Hamza Azam17/06/2025 00:00:00Shaikh Muhammad Hamza Azam15/07/2025 12:20:18
RA-0027-2530/06/2025PDRisk associated with nitrosamine contaimination in products   N/ARisk under assessment Shaikh Muhammad Hamza Azam30/06/2025 08:33:17Shaikh Muhammad Hamza Azam15/07/2025 12:40:11
RA-0028-2503/07/2025PDRisk associated with change in formulation of Byvas 10mg, 5mg and 2.5mg tablet to improve similarity factor in Comparative dissolution profile (CDP).MediumLow1. 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 31/03/2026In-progressAcceptedShaikh Muhammad Hamza Azam03/07/2025 00:00:00Shaikh Muhammad Hamza Azam15/07/2025 11:47:12
RA-0029-2503/07/2025PDRisk associated with Change in formulation of Gouric 80mg and 40mg tablet to improve similarity factor in Comparative dissolution profile (CDP).In-progress  N/ARisk under assessment Shaikh Muhammad Hamza Azam03/07/2025 00:00:00Shaikh Muhammad Hamza Azam17/07/2025 07:47:42
RA-0030-2531/07/2025PDRisk 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 Azam31/07/2025 08:29:12  
RA-0031-2531/07/2025QARisk associated with the cleaning validation of insoluble API’sIn-progress  N/A  Shaikh Muhammad Hamza Azam06/08/2025 09:56:51  
RA-0032-2501/08/2025QARisk associated with BDR softwareIn-progress  N/A  Shaikh Muhammad Hamza Azam12/08/2025 10:29:14  
RA-0033-2508/08/2025RARisk associated with new launch of Uroease (Dutasteride+Tamsulosin) Caps 0.5mg/0.4mg thorugh contract manufacturingIn-progress  N/A  Shaikh Muhammad Hamza Azam11/09/2025 15:24:34  
RA-0034-2513/08/2025SCMRisk associated with source development and approval through online software-based systemIn-progress  N/A  Shaikh Muhammad Hamza Azam12/09/2025 08:28:14  
RA-0035-2515/08/2025QCRisk associated with anti-microbial resistanceIn-progress  N/A  Shaikh Muhammad Hamza Azam12/09/2025 08:30:41  
RA-0036-2521/08/2025PDChange in formulation of Oxivort 10mg tabletIn-progress  N/A  Shaikh Muhammad Hamza Azam12/09/2025 08:32:11  
RA-0037-2529/08/2025PDRisk associated with change in coating material of products (list attached)In-progress  N/A  Shaikh Muhammad Hamza Azam12/09/2025 10:26:16  
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2024-2025 QA.