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| RCA-0001-26 | 05/01/2026 | As per DR-0001-26-P, During labeling on the self-adhesive auto-labeling machine, label wrinkling was observed due to incompatibility between label and bottle dimensions. | After root cause analysis it is concluded that wrinkling problem was observed because labels for Zi-AD 5mg/5ml syrup was designed for manual labelling process by considering benchmark product Klevra Oral Solution while in actual lebelling process is carried out on auto labeling machine. Further QC designee did not check the physical application of the label by pasting on the bottles. | Process was stopped and deviation has been raised. | 5WHY | Closed | Muneeb Shahid | Pharma | Muneeb Shahid | 06/01/2026 15:58:47 | Syed Mohammad Zohaib Ali Rizvi | 18/06/2026 14:56:54 |
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| RCA-0002-26 | 09/03/2026 | As per DR-0002-26. The old artwork unit cartons (Material Code: 1200000776) Lot no: 68511 were issued for packaging of Guatemala (Export) PS packs instead of the revised artwork unit cartons. Consequently, overprinting was performed on the old artwork unit cartons. | Old artwork unit cartons were issued due to inadequate communication and coordination between Regulatory Affairs (RA) and Business Development (BD), resulting in delayed initiation and implementation of the revised artwork Change Control request. | Printed Unit Cartons (Material Code: 1200004645), Lot No. 68511, were placed on hold, and a deviation was raised. | 5WHY | Closed | Syed Zohaib Ali | Pharma | Syed Mohammad Zohaib Ali Rizvi | 17/03/2026 10:08:50 | Syed Mohammad Zohaib Ali Rizvi | 16/06/2026 18:06:54 |
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| RCA-0003-26 | 08/04/2026 | As per DR-0004-26-P, During compression of Sacvin 100 mg Tablets, Batch No. 6C209, on ZP37B-II Compression Machine, CAM breakage occurred due to loosening of the CAM bolt during operation. | Critical fasteners (CAM bolts) were not identified during PM checklist development; therefore, inspection and tightening of CAM bolts were not included in the quarterly preventive maintenance program, resulting in bolt loosening and subsequent CAM breakage. | 1. The concerned QAI was informed immediately, and the tablets compressed during the CAM breakage were segregated and set aside for rejection. The batch was placed on hold.
2. The Engineering Department was immediately notified to rectify the issue.
| 5WHY | Closed | Syed Zohaib Ali | Pharma | Syed Mohammad Zohaib Ali Rizvi | 23/04/2026 10:00:56 | Syed Mohammad Zohaib Ali Rizvi | 16/06/2026 18:16:31 |
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| RCA-0004-26 | 28/04/2026 | During the Product Quality Review (PQR) of X-Plended 20mg Tablets and Avsar Plus 160/10/12.5mg Tablet, it was identified that the obsolete tablet compression machine Fette P2000 and ZPW23D respectively remains listed in the BMR equipment checklist. However, other listed compression machines were used for maunfacturing. | Lack of a defined and controlled procedure for equipment decommissioning and associated updates to controlled manufacturing documents (e.g., BMR equipment lists). | The observation and corresponding recommendation were documented in the Product Quality Review (PQR). A Root Cause Analysis (RCA) has been initiated to evaluate the underlying cause of the discrepancy and to define appropriate corrective and preventive actions (CAPA).
| 5WHY | Closed | Syed Zohaib Ali | Pharma | Syed Mohammad Zohaib Ali Rizvi | 28/04/2026 16:01:57 | Syed Mohammad Zohaib Ali Rizvi | 03/06/2026 12:47:29 |
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| RCA-0005-26 | 18/05/2026 | As per DR-0005-26-P, During granulation of Nise 100 mg Tablets, Batch No. 6F040, while off-loading the materials from cage onto a pallet, the polybags containing Colloidal Silicon Dioxide (Aerosil 200), Talcum Powder, and Magnesium Stearate accidentally slipped from the cage and fell onto the floor. Consequently, all three polybags got ruptured, resulting in spillage of the materials onto the floor.
| Absence of a formal system and procedure for qualification, testing, and approval of polybags used for material handling, resulting in the use of polybags with inadequate load-bearing capacity. | 1. QAI was informed, and the spilled material was identified, collected and segregated for destruction.
2. Additional material was requested for batch continuation.
3. Deviation has been raised.
| 5WHY | Closed | Syed Zohaib Ali | Pharma | Syed Mohammad Zohaib Ali Rizvi | 03/06/2026 12:47:54 | Syed Mohammad Zohaib Ali Rizvi | 16/06/2026 18:24:15 |
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| RCA-0006-26 | 23/05/2026 | As per Deviation report no: DR-0006-26-P, during startup of BGK-350 for film coating of Erlina Plus XR 25/5/1000 mg Tablets, the BGK-350 Coating machine tripped and could not restart.
| The BGK-350 coating machine tripped due to burnout of the exhaust motor and failure of the VFD. Investigation revealed that a damaged motor bearing caused excessive friction and mechanical load, resulting in overheating and subsequent failure of the motor and VFD. Review of the previous preventive maintenance records confirmed that no abnormality in the motor bearings had been observed prior to the incident. Therefore, the equipment failure occurred during routine operation and resulted in interruption of the coating process. | 1. Informed to QA and intimated to engineering team for the rectification of the issue.
2. Coating solution was set aside in enclosed S.S container until the rectification of issue.
3. Deviation was raised.
| 5WHY | Closed | Syed Zohaib Ali | Pharma | Syed Mohammad Zohaib Ali Rizvi | 06/06/2026 08:17:58 | Syed Mohammad Zohaib Ali Rizvi | 03/07/2026 10:26:50 |
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| RCA-0007-26 | 25/05/2026 | As per DR-0007-26-P, During encapsulation of Zoltar 20mg Capsule, weight variation observed to be exceeding the defined limits. | Upon investigation it was identified that, due to of non-uniform and twin pallets weight variation was exceeding the defined limit. | 1. Informed to concerned QAI and process was hold.
2. Deviation was raised.
| Fishbone Diagram | Closed | Syed Zohaib Ali | Pharma | Syed Mohammad Zohaib Ali Rizvi | 06/06/2026 08:19:24 | Syed Mohammad Zohaib Ali Rizvi | 18/06/2026 12:55:33 |