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| DR-0001-26-P | 02/01/2026 | 02/01/2026 | Production | Minor | ZI AD Labeling issue | 5N281 | During labeling on the self-adhesive auto-labeling machine, label wrinkling was observed due to incompatibility between label and bottle dimensions.
| RCA-0001-26 | CAPA-0001-26 | Closed | 05/01/2026 | Muneeb Shahid | 02/01/2026 | Syed Mohammad Zohaib Ali Rizvi | 16/06/2026 |
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| DR-0002-26-P | 02/03/2026 | 09/03/2026 | Packaging area | minor | Issuance of old artwork Unit carton for Guatamala (export) PS) | 5L128 | 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. | RCA-0002-26 | CAPA-0004-26 | Closed | 09/03/2026 | Syed Mohammad Zohaib Ali Rizvi | 09/03/2026 | Syed Mohammad Zohaib Ali Rizvi | 16/06/2026 |
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| DR-0003-26-P | 09/03/2026 | 09/03/2026 | Production | major | Hardness results exceeding the upper control limit | 6B302 | During compression of Avsar Plus 160/10/25, Batch No. 6B302, on the ZPW-23 compression machine, tablet hardness values were observed to be in the range of 5–20 kg, exceeding the upper specification limit of 15 kg as defined in the approved BMR. | N/A | CAPA-0005-26 | Closed | 09/03/2026 | Syed Mohammad Zohaib Ali Rizvi | 09/03/2026 | Syed Mohammad Zohaib Ali Rizvi | 18/06/2026 |
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| DR-0004-26-P | 07/04/2026 | 08/04/2026 | Prodution | Major | CAM Breakage During Compression | 6C209 | 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.
| RCA-0003-26 | CAPA-0007-26 | Closed | 08/04/2026 | Syed Mohammad Zohaib Ali Rizvi | 09/04/2026 | Syed Mohammad Zohaib Ali Rizvi | 18/06/2026 |
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| DR-0005-26-P | 15/05/2026 | 15/05/2026 | Production | minor | Spillage of material | 6F040 | 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.
| RCA-0005-26 | CAPA-0011-26 | Closed | 18/05/2026 | Syed Mohammad Zohaib Ali Rizvi | 15/05/2026 | Syed Mohammad Zohaib Ali Rizvi | 17/07/2026 |
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| DR-0006-26-P | 23/05/2026 | 23/05/2026 | Production | Minor | BGK Coating 350 tripped and could not restart | 6D138 | 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.
| RCA-0006-26 | CAPA-0012-26 | Closed | 23/05/2026 | Syed Mohammad Zohaib Ali Rizvi | 25/05/2026 | Syed Mohammad Zohaib Ali Rizvi | 19/09/2026 |
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| DR-0007-26-P | 25/05/2026 | 25/05/2026 | Production | Minor | Document unavailability | N/A | During a visit to the ZP37-BI compression machine cubical, it was observed that the relevant SOP was not available in the SOP Holder designated for SOPs at the relevant machine PAL. | N/A | CAPA-0013-26 | Closed | 25/05/2026 | Syed Mohammad Zohaib Ali Rizvi | 25/05/2026 | Syed Mohammad Zohaib Ali Rizvi | 21/09/2026 |
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| DR-0008-26-P | 30/07/2026 | 30/07/2026 | Issuance of P.O. for Erli 25mg Tablet instead of Glyzempa 25mg Tablet | minor | Issuance of P.O | 6F109, 6F110 | Initially, Glyzempa 25mg Tablet Batch no: 6F109 and 6F110 were manufactured for export order. However, the packaging order of Erli 25mg Tablets were issued instead of Glyzempa 25mg Tablets.
| N/A | CAPA-0019-26 | Closed | 30/07/2026 | Syed Mohammad Zohaib Ali Rizvi | 15/07/2026 | Syed Mohammad Zohaib Ali Rizvi | 18/09/2026 |
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| DR-0009-26-P | 30/07/2026 | 30/07/2026 | QC Packaging Lab | minor | Discrepancy in artwork of Shipper carton | 0000082321, 0000082322 0000082600, 0000082601 | During inspection of the first consignment of shipper cartons received from M/s Grace Packages, it was observed that the company logo was printed on all four sides of the shipper cartons instead of the approved artwork, which requires the logo to be printed only on the front and back sides. | N/A | CAPA-0020-26 | Closed | 31/07/2026 | Syed Mohammad Zohaib Ali Rizvi | 23/07/2026 | Syed Mohammad Zohaib Ali Rizvi | 18/09/2026 |
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| DR-0010-26-P | 13/08/2026 | 13/08/2026 | QC | minor | Inadequate Sample Quantity Recording Range in SAP | List attatched | As per the applicable procedure, the total required sample quantity for each lot of API is 0.06 kg (60g), which is to be collected from 80 containers, resulting in a required sample quantity of 0.00075 kg per container. However, an issue has been identified during the entry of the sampled quantity in SAP, as the system permits the sampled quantity to be entered only up to three decimal places. Consequently, the required quantity of 0.00075 Kg per container cannot be accurately recorded, which may result in incorrect automatic sample quantity deduction in SAP. | N/A | CAPA-0023-26 | Closed | 13/08/2026 | Syed Mohammad Zohaib Ali Rizvi | 13/08/2026 | Syed Mohammad Zohaib Ali Rizvi | 19/09/2026 |
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| DR-0011-26-P | 22/08/2026 | 24/08/2026 | MIS, QC, Engr., RA, HR | Minor | IT Network Disruption | N/A | WHAT:
Description of deviation:
An IT network disruption was identified, resulting in the unavailability of multiple GMP software systems, data and backup files. mentioned below
Department Name Software Functionality
QC Shimadzu, Agilent, Thermo, Spectrum Support QC laboratory activities by managing samples, controlling instruments, and processing analytical data.
Engineering BMS Electronic monitoring and data backup of temperature, RH, and differential pressure of cubicles.
Regulatory Affairs Regulatory Portal Management of Regulatory Data.
HR Timetrax employee attendance management, including time-in/time-out, attendance tracking, shift management, and working-hour records. | RCA-0007-26 | | In Progress | | Syed Mohammad Zohaib Ali Rizvi | 19/09/2026 | Syed Mohammad Zohaib Ali Rizvi | 20/09/2026 |