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| DR-0001-25-P | 13/01/2025 | 13/01/2025 | QC Raw material section | Minor | Discrepancy in GRN and Physical Quantity for Alendronate Sodium Raw Material, Batch No. 55357 | Batch: 55357, Lot No's. 10000071224, 10000071225 | We have received Alendronate Sodium raw material, batch no. 55357. The quantity mentioned in the GRN documents for each lot is 10 kg, but physically, there is one container of 20 kg present in the warehouse quarantine area. GRN has been created, however, the batch numbers for both line items are the same, and the QC inspection lots are different. | RCA-0001-25 | CAPA-0001-25 | Closed | 14/01/2025 | 13/01/2025 | 12/04/2025 | | Hamza Ahmed |
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| DR-0002-25-P | 16/01/2025 | 16/01/2025 | QC Raw material | Major | Ambiguity in Raw Material Packaging: Velpatasvir & Copovidone Solid Disp. 50:50 and Sofosbuvir | 1. B# 55718, Lot# VEP-2410002, GRN# 500015191-(MVT:101). 2. B# 55720, Lot# S104A(1190307-88-0), GRN# 5000115192-(MVT:101) | We have received two raw materials: Velpatasvir & Copovidone Solid Disp. 50:50, batch no. 55718, and Sofosbuvir, batch no. 55720. During the inspection of the raw materials, the sampling personnel identified an ambiguity, as both materials were found in the same secondary container. However, both materials were in intact, separate bags and each bag labeled with proper identification. | RCA-0002-25 | CAPA-0002-25 | Closed | 17/01/2024 | 17/01/2025 | 12/04/2025 | | Hamza Ahmed |
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| DR-0003-25-P | 22/01/2025 | 22/01/2025 | Production (Blistering) | Major | Inosita Plus XR 100/1000mg Tablet (Iraq) | 4M167 | During blistering, it was observed that perforation plates was pressing the tablets , resulting damage of the tablet. Approximately half of the batch was blistered with such issue. | RCA-0003-25 | CAPA-0003-25 | Closed | 29/01/2025 | 23/01/2025 | 29/01/2025 | | |
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| DR-0004-25-P | 31/01/2025 | 31/01/2025 | Pharma | Minor | Two lots of API in picklist | 5A360 5A361 5A362 5A363 5A364 | With reference to DR-0004-25-P, During the dispensing of Evorox suspension it was observed that API was issued in two lots, while the quantity of the first lot was sufficient to allocate for the first two batches. Details of API: BATCH NUMBER :5A360 Material Name: Cefuroxime Axetil Amorphous (for susp.) Total qty required in batch: 10.471 kg SAP Batch# 0000033194 Issued Qty: 5.026 kg Balance qty 17.908 kg validity of lot: 07.06.26 SAP Batch# 0000055217 Issued Qty: 5.769 kg Balance qty 83.158 kg validity of lot: 24.09.27 BATCH NUMBER :5A361 Material Name: Cefuroxime Axetil Amorphous (for susp.) Total qty required in batch: 10.471 kg SAP Batch# 0000033194 Issued Qty: 5.026 kg Balance qty 12.880 kg validity of lot: 07.06.26 SAP Batch# 0000055217 Issued Qty: 5.769 kg Balance qty 77.389 kg validity of lot: 24.09.27 BATCH NUMBER :5A362 Material Name: Cefuroxime Axetil Amorphous (for susp.) Total qty required in batch: 10.471 kg SAP Batch# 0000033194 Issued Qty: 5.026 kg Balance qty 07.856 kg validity of lot: 07.06.26 SAP Batch# 0000055217 Issued Qty: 5.769 kg Balance qty 71.620 kg validity of lot: 24.09.27 BATCH NUMBER :5A363 Material Name: Cefuroxime Axetil Amorphous (for susp.) Total qty required in batch: 10.471 kg SAP Batch# 0000033194 Issued Qty: 5.026 kg Balance qty 02.830 kg validity of lot: 07.06.26 SAP Batch# 0000055217 Issued Qty: 5.769 kg Balance qty 65.851 kg validity of lot: 24.09.27 BATCH NUMBER :5A360 Material Name: Cefuroxime Axetil Amorphous (for susp.) Total qty required in batch: 10.471 kg SAP Batch# 0000033194 Issued Qty: 2.830 kg Balance qty 0.000 kg validity of lot: 07.06.26 SAP Batch# 0000055217 Issued Qty: 8.061 kg Balance qty 46.777 kg validity of lot: 24.09.27 | RCA-0004-25 | CAPA-0004-25 | Closed | 31/01/2025 | 31/01/2025 | 05/05/2025 | Hamza Ahmed | Muneeb Shahid |
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| DR-0005-25-P | 14/02/2025 | 17/02/2025 | Warehouse (Dispensing) | Major | Discrepancy in the quantity of diluent (sucrose) as the picklist quantity differs from the calculated quantity. | 5B137, 5B138, 5B139 | Discrepancy observed in the picklist Of Scifix 100mg suspension, Batch No. 5B137, 5B138 and 5B139 that is, quantity of sucrose is found wrong in the picklist as the quantity in the picklist is 202.000 KG but the actual quantity is found after the verification of calculation of API with adjusted excipient 201.910 KG. | RCA-0005-25 | CAPA-0006-25 | Closed | 19/02/2025 | 17/02/2025 | 13/04/2025 | Muneeb Shahid | Hamza Ahmed |
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| DR-0006-25-P | 20/03/2025 | 20/03/2025 | Pharma | Major | Out of specification results observed in assay dissolution and CU for Ertugliflozin in Eglaro-S Tablet 5/100 mg | 5B240 | Out of specification results observed in assay , dissolution and CU for Ertugliflozin in Eglaro-S Tablet 5/100 mg Batch# 5B240
Assay:
Min: 73.72%, Max: 74.06%, Avg.: 73.89%
Dissolution:
Min: 71.42%, Max: 75.83%, Avg.: 73.83%
Content Uniformity= 24.22
| N/A | CAPA-0010-25 | Closed | 26/03/2025 | 20/03/2025 | 22/04/2025 | Hamza Ahmed | Muneeb Shahid |
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| DR-0007-25-P | 12/04/2025 | 12/04/2025 | Production (Compression) | major | Metal Detector not working on T-700 machine. | 5C160 | During compression of product Avsar 160/10/12.5 it was observed that one out of two metal detectors (Equipment ID number: EMP-COM-04-33-02) is not working properly. | RCA-0006-25 | CAPA-0011-25 | Closed | 16/04/2025 | 15/04/2025 | 21/04/2025 | Muneeb Shahid | Muneeb Shahid |
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| DR-0008-25-P | 23/04/2025 | 23/04/2025 | Vial Filling (Ceph) | major | Malfunctioning of Vacuum pump | 5D061 | During vial filling process of Bestrix 250mg injection 5D061, the filling operation was stopped due to vacuum pump malfunction. | RCA-0009-25 | CAPA-0015-25 | Closed | 23/04/2025 | 21/05/2025 | 27/05/2025 | Muneeb Shahid | Muneeb Shahid |
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| DR-0009-25-P | 24/04/2025 | 24/04/2025 | Production (Compression) | Major | Compression Defects | 5C100 | Capping problem has been encountered in Lowplat Plus 75mg Tablet, B#5C100 on BG-400 coating machine. | RCA-0010-25 | CAPA-0016-25 | Closed | | 21/05/2025 | 27/05/2025 | Muneeb Shahid | Muneeb Shahid |
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| DR-0010-25-P | 20/05/2025 | 21/05/2025 | Warehouse (Dispensing) | minor | material shortage and GI cancellation | 5F073 / 0000052613 / 5000111135 | During the dispensing of API of Actiflor 250mg sachet Batch number 5F073, it is observed that the API was found short, due to this, warehouse officer mistakenly cancelled whole GI instead on one raw material. | RCA-0011-25 | CAPA-0017-25 | Closed | | 27/05/2025 | 27/05/2025 | Muneeb Shahid | Muneeb Shahid |
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| DR-0011-25-P | 10/03/2025 | 26/05/2025 | | minor | GRN reversal of Sitagliptin Phosphate Monohydrate | Batch number 0000058521, 0000058522 Lot# 1827-0001-25006, Lot# 1827-0001-25007 GRN 5000120071, 5000120072 | The two lots of Sitagliptin Phosphate Monohydrate Lot#58521 and 58522 have been reverted by Finance department. It was identified at the time of release of lot in SAP | RCA-0012-25-P | CAPA0-0018-25 | In Progress | | 27/05/2025 | 27/05/2025 | Muneeb Shahid | Muneeb Shahid |
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| DR-0012-25-P | 21/05/2025 | 27/05/2025 | QC ( FP Analytical) | major | Out of specification results observed in dissolution of Xcept 15mg tablet. | 5D211 | Out of specification results observed in dissolution of Xcept 15mg tablet
Dissolution:
Min: 49.75%, Max: 57.15%, Avg.:52.84% | RCA-0013-25 | CAPA-0019-25 | In Progress | | 27/05/2025 | | Muneeb Shahid | |
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| DR-0013-25-P | 04/06/2025 | 04/06/2025 | Production (Compression) | minor | Thickness Issue during compression | 5F174 | A deviation was observed during the compression of Avsar Plus 160/10/25mg Tablets, Batch #5F174 on the ZPW-23 compression machine, where the documented thickness limit of 4.30 to 5.10 mm as per BMR was not achieved, resulting in tablets being produced outside the specified range. | RCA-0014-25 | CAPA-0020-25 | In Progress | | 04/06/2025 | | Muneeb Shahid | |
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| DR-0014-25-P | 16/06/2025 | 17/06/2025 | Production (Packing) | minor | Excess number of capsules produced | 4M013 | As per generated PO, excess number of blisters found at packing stage after completion of required quantity of Orslim 120mg Capsule | RCA-0015-25 | CAPA-0022-25 | Opened | | 17/06/2025 | | Muneeb Shahid | |
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| DR-0015-25-P | 25/06/2025 | 25/06/2025 | Warehouse (Dispensing) | minor | material shortage during dispensing | 5G170 | During dispensing of Busonide DPI 400/12 mcg Capsule Batch number 5G170, it was observed that the quantity of HPMC Shell Budesonide + Formoterol 400/12 mcg found physically short i.e 3.300kg (68,922 Nos) and there is no lot available to complete the batch. | RCA-0016-25 | CAPA-0023-25 | In Progress | | 26/06/2025 | | Muneeb Shahid | |