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| RCA-0001-26 | 05/01/2026 | As per DR-0001-26-P, during the Performance Qualification (PQ) of the self-adhesive auto-labeling machine, wrinkling of labels was observed due to incompatibility of label dimensions with the bottles. | 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 lable by pasting on the bottles. | Process was stopped and deviation has been raised. | 5 Why's | Closed | Muneeb Shahid | Pharma | Muneeb Shahid | 06/01/2026 15:58:47 | Syed Mohammad Zohaib Ali Rizvi | 08/05/2026 17:59:24 |
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| RCA-0002-26 | 09/03/2026 | As per DR-0002-26. The old artwork unit carton (Material Code: 1200000776) were issued as per the pick list for Guatemala (export) PS packs, instead of revised artwork unit cartons. As a result, over printing was performed on the old artwork unit cartons and afterwards new picklist was issued for issuance of New Artwork unit carton. | Old artwork unit cartons were issued because the picklist was generated before the decision of artwork revision and revised picklist was issued because supply chain has rights in SAP to revise the picklist without approval from QA. | Printed Unit Cartons (Material Code:1200004645) Lot no: 68511 were placed on hold and has deviation has been raised. | 5WHY | Closed | Syed Zohaib Ali | Pharma | Syed Mohammad Zohaib Ali Rizvi | 17/03/2026 10:08:50 | Syed Mohammad Zohaib Ali Rizvi | 08/04/2026 10:56:32 |
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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. | Based on the Ishikawa Diagram and 5-Why analysis, the root cause of CAM breakage was inadequate quarterly preventive maintenance controls, with no defined procedure for inspection of CAM wear and tear and verification of bolt tightening. The PM checklist lacked torque specifications and bolt-tightening verification steps, resulting in improper fastening. Consequently, the CAM fixing bolt loosened during operation, leading to displacement and breakage of the CAM. Contributing factors included machine-related issues such as vibration and absence of a locking mechanism, and measurement gaps including no RPM recording, inadequate lubrication control, and no defined operating RPM range, which may have further contributed to bolt loosening. | 1. Concerned QAI was informed and batch was transferred to WIP.
2. Engineering team was Immediately notified to rectify the issue.
| Ishikawa Diagram and 5WHY | Closed | Syed Zohaib Ali | Pharma | Syed Mohammad Zohaib Ali Rizvi | 23/04/2026 10:00:56 | Syed Mohammad Zohaib Ali Rizvi | 08/05/2026 18:16:03 |
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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 manufacturing.
| 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) was 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 | 14/05/2026 11:36:53 |