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| DR-0001-24-P | 12/01/2024 | 15/01/2024 | Pharma | Minor | Testing logbook of unit carton(without header) | N/A | PM Testing logbook of unit carton and master carton (Pharmevo & Toll client) having Doc# QCP/5/021 has received to QC without header having information (GRN no. QC lot #, item description, item code and batch no). | N/A | N/A | Closed | 18/01/2024 | 15/01/2024 | 08/05/2024 | Hamza Ahmed | Hamza Ahmed |
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| DR-0002-24-P | 16/01/2024 | 17/01/2024 | Pharma | Minor | 4Kg Containers of Ceftriaxone Sodium | 4A2021, 4A202 | Two containers of Ceftriaxone Sodium have received to warehouse each contain 4Kg of Ceftriaxone Sodium instead of 10Kg. | N/A | CAPA-0001-24 | Closed | 19/01/2024 | 17/01/2024 | 21/03/2024 | Hamza Ahmed | Hafsa Fatima |
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| DR-0003-24-P | 17/01/2024 | 18/01/2024 | Pharma | Minor | coating material | 4A136 | At the time of material receiving of Inosita Plus 50/1000mg Tablet B.No 4A136 it was observed that in coloring material iron oxide red was found missing in lot 3. | RCA-0001-24 | CAPA-0002-24 | Closed | 19/01/2024 | 22/01/2024 | 10/05/2024 | Hamza Ahmed | Hamza Ahmed |
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| DR-0004-24-P | 29/01/2024 | 29/01/2024 | Pharma | Minor | Scifix bottles color issue | 4A255 | At batch receiving stage of primary packaging material of Scifix suspension 30ml it was observed that the label colored was green while the ring on the bottle of scifix suspension was red instead of green. | RCA-0002-24 | CAPA-0004-24 | Closed | 29/01/2024 | 29/01/2024 | 10/05/2024 | Hamza Ahmed | Hamza Ahmed |
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| DR-0005-24-P | 29/01/2024 | 29/01/2024 | Pharma | Minor | Wrong Manufacturing Date | 4A003 | At the time of line clearance at packaging stage of Floractiva sachet B.No 4A003 sachet it was observed that manufacturing date was printed wrong on unit cartonsi.e. Jan-23 instead of Jan-24.
| N/A | N/A | Closed | 09/02/2024 | 01/02/2024 | 11/05/2024 | | Hamza Ahmed |
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| DR-0006-24-P | 29/01/2024 | 29/01/2024 | Pharma | Major | Telmisartan was fallen down | 4A245 | During the granulation of Telsarta-A 5/80mg Tablet B.No 4A245 it was observed that at the time of solution preparation, Telmisartan was fallen down on floor. i.e. 0.630Kg. | RCA-0003-24 | CAPA-0005-24 | Closed | 08/02/2024 | 01/02/2024 | 03/07/2024 | | Hamza Ahmed |
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| DR-0007-24-P | 02/03/2024 | 04/03/2024 | Pharma | Minor | malfunctioning in coating machine BGK-400E | 4B214 | Before startup of coating operation for Inosita plus 50/1000mg Tablet B.No 4B214 at BGK-400E it was observed that machine was malfunctioning. Coating solution of said product was prepared. | RCA-0004-24 | CAPA-0009-24 | Closed | 04/03/2024 | 05/03/2024 | 17/05/2024 | Hamza Ahmed | Hamza Ahmed |
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| DR-0008-24-P | 04/03/2024 | 04/03/2024 | Pharma | Minor | Insufficient space in unit carton | 4A165 | At the time of line clearance of Erlina Plus XR 12.5mg/1000mg B.No 4A165 for Guatemala (PS) it was observed that direction insert cannot fixed in the unit carton due to insufficient space in unit carton. | RCA-0005-24 | CAPA-0010-24 | Closed | 04/03/2024 | 13/03/2024 | 17/05/2024 | Hamza Ahmed | Hamza Ahmed |
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| DR-0009-24-P | 26/03/2024 | 26/03/2024 | Pharma | Minor | Aluminum foil of securin | 4B289 | At the time of blistering operation of securin 2.5mg Tab B.No 4B289, it was observed that aluminum foil received for the blistering process is according to the round punch while core tablets of securin 2.5mg Tab have oblong shape. | RCA-0006-24 | CAPA-0011-24 | Closed | 03/04/2024 | 09/04/2024 | 11/05/2024 | Hamza Ahmed | Hamza Ahmed |
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| DR-0010-24-P | 09/04/2024 | 09/04/2024 | Pharma | Minor | Wrong price in Item code | N/A | Item code 1200003865 is opened with wrong price in master data. | N/A | N/A | Closed | 09/04/2024 | 09/04/2024 | 11/05/2024 | Hamza Ahmed | Hamza Ahmed |
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| DR-0011-24-P | 09/04/2024 | 09/04/2024 | Pharma | Minor | Missing dispensing tag | 4A197 | During batch documents audit at packing stage, it has been observed that all core dispensing tags of
Zibes 5mg tablet, 4A197 have been found missing. | RCA-0007-24 | CAPA-0013-24 | Closed | 09/04/2024 | 09/04/2024 | 11/05/2024 | Hamza Ahmed | Hamza Ahmed |
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| DR-0012-24 | 23/04/2024 | 23/04/2024 | Pharma | Minor | reverted GRNS | 42098,42099,42100 | During the quarantine list review it was observed that following GRN 5000096018, 5000096020 and 5000096021 of Orlistat Pellets have been reverted by warehouse. | N/A | N/A | Closed | 30/04/2024 | 23/04/2024 | 12/05/2024 | Hamza Ahmed | Hamza Ahmed |
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| DR-0013-24 | 26/04/2024 | 29/04/2024 | Pharma | Minor | Low grammage | 42593 | At the time testing of U/C X-plended 10mg Tablet 100's Philippines it was observed that grammage of U/C received with 300grams instead of 350grams. | N/A | N/A | Closed | 29/04/2024 | 29/04/2024 | 13/05/2024 | Hamza Ahmed | Hamza Ahmed |
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| DR-0014-24-P | 17/05/2024 | 17/05/2024 | Pharma | Minor | Wrong PO | 43288 &43289 | GRN of MCC 101 & MCC 102 are created on wrong PO. | N/A | N/A | Closed | 21/05/2024 | 17/05/2024 | 06/06/2024 | Hamza Ahmed | Hamza Ahmed |
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| DR-0015-24-P | 18/05/2024 | 18/05/2024 | Production / Non-Ceph | Major | Exceeding lead time | 4C224 | At the time of material receiving of Klevra oral solution B.No 4C224 for manufacturing of the batch it was observed that:
. Batch lead time of Klevra oral solution B.No 4C224 has been exceeded at dispensing material stage as per SOP PRG/2/019.
. | RCA-0008-24 | CAPA-0015-24 | Closed | 24/05/2024 | 20/05/2024 | 08/06/2024 | Hafsa Fatima | |
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| DR-0016-24-P | 24/05/2024 | 24/05/2024 | Warehouse | Major | Material -API spillage | 4F200 | During dispensing of Sacvin 50mg Tablet B.No 4F200 it was observed that dispensed material name
Sacubitril+Valsartan was fallen down from dispensing cage and 3.600Kg of the material was pilled on the floor.
| RCA-0009-24 | CAPA-0016-24 | Closed | 24/05/2024 | 24/05/2024 | 08/06/2024 | Hafsa Fatima | Hamza Ahmed |
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| DR-0017-24-P | 24/05/2024 | 24/05/2024 | Production | Major | Coating material Eudragit IR Ready mix white | N/A | During coating of X-Plended 20mg Tablet roughness and edges issues were observed due to change in coating material i.e. Eudagrit instead of Opadry White 03F580033. | RCA-0010-24 | CAPA-0017-24 | Closed | 27/05/2024 | 24/05/2024 | 04/07/2024 | Hafsa Fatima | |
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| DR-0018-24-P | 11/06/2024 | 12/06/2024 | Pharma | Minor | artwork Revision | 4D131 | Order of Estar 10mg tab batch#4D131 GTM was not completed due to the shortage of Aluminum foil with old artwork. | N/A | N/A | Closed | 21/06/2024 | 12/06/2024 | 20/07/2024 | Hamza Ahmed | Hamza Ahmed |
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| DR-0019-24-P | 25/07/2024 | 25/07/2024 | Pharma | Minor | Rev of U/C artwork Inosita Plus 50/1000mg CP (GTM) 28's | 4G045 | Order of Inosita Plus 50/1000mg Tab (GTM) 28's B.No 4G045 was not completed due to shortage of U/C with old artwork. | N/A | N/A | Closed | 07/08/2024 | 25/07/2024 | 07/08/2024 | Hamza Ahmed | Hamza Ahmed |
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| DR-0020-24-P | 07/08/2024 | 07/08/2024 | Pharma | Major | Delay in export order of Nigeria for the product Nucard 80 and 160mg Tablet | List Attached | Export order was received from Nigeria but certain reason order confirmation delayed from the partner. | N/A | CAPA-0018-24 | Closed | 08/08/2024 | 07/08/2024 | 13/08/2024 | Hamza Ahmed | Zafran Meer |
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| DR-0021-24-P | 11/09/2024 | 11/09/2024 | Pharma | Major | Reconcilation not performed | 4J224 | During packing process of Klevra 500mg/5ml oral Solution batch number 4J224, it was observed that reconciliation of bottle blowing & liquid filling process in batch document was not performed. | RCA-0011-24 | CAPA-0019-24 | Closed | 13/09/2024 | 11/09/2024 | 13/11/2024 | Zafran Meer | Zafran Meer |
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| DR-0022-24-P | 13/09/2024 | 13/09/2024 | Pharma | Major | Line clearance failure | 4J139 | Packaging material of Byvas 5mg Tablet batch number 4J139 was arranged on belt number 03 prior to filling of line clearance document
| RCA-0012-24 | CAPA-0020-24 | Closed | 10/10/2024 | 16/09/2024 | 13/11/2024 | Zafran Meer | Zafran Meer |
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| DR-0023-24-P | 13/09/2024 | 13/09/2024 | Quality Control | Minor | Entry missing in Logbook | 4J116 | During an official visit in the QC lab it was observed that entry of Onita 2g sachet was missed in logbook format# QCG/5/083 on 29-08-2024. | RCA-0013-24 | CAPA-0022-24 | Closed | 20/09/2024 | 23/09/2024 | 18/11/2024 | Zafran Meer | Zafran Meer |
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| DR-0024-24-P | 20/09/2024 | 20/09/2024 | Pharma | Major | Master carton issue | 4J145/ lot no. 0000049108 | At the time of Hoonga Blister Machine setting for X-Plended 10mg Tablet, Batch No.: 4J145 it was observed by the operator that size of the unit carton is smaller than previously used unit carton but the size of master carton is same as previous i.e. MC-09. | RCA-0014-24 | CAPA-0021-24 | Closed | 11/10/2024 | 30/09/2024 | 13/11/2024 | Hamza Ahmed | Zafran Meer |
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| DR-0025-24-P | 30/09/2024 | 30/09/2024 | Pharma | Major | NEXT Revision of POI and BPR Issue | N/A | Packaging order issuance "POI "and Batch packaging record "BPR" of Evokalm XR 200mg tablet were approved on 09-06-2024 and need to be reviewed on 09-06-2024 as per the review date mentioned on the document. This POI and BPR could not reviews within timeline. | RCA-0015-24 | CAPA-0023-24 | Closed | 11/10/2024 | 25/10/2024 | 02/11/2024 | Zafran Meer | Zafran Meer |
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| DR-0026-24-P | 24/10/2024 | 24/10/2024 | Pharma | Major | Less comulative yield observed at final packing stage | 4K086 & 4K011 | Less cumulative yield have been observed in Lowplat Plus 75mg tablet, 4K086 (96.26%) and 4K011 (96.65%) at packing stage. i.e. yield limit is 97 - 103% | RCA-0016-24 | CAPA-0024-24 | In Progress | | 28/10/2024 | 02/11/2024 | Zafran Meer | Zafran Meer |
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| DR-0027-24-P | 25/10/2024 | 25/10/2024 | Pharma | Minor | Discrepancy in pack size in BPR | 4K215 | In Klevra XR 500mg tablet (GTM), pack size mentioned on BPR is not correct. actual pack size is 6x5's Pack size in BPR is 3x10's | RCA-0017-24 | CAPA-0025-24 | In Progress | | 28/10/2024 | 02/11/2024 | Zafran Meer | Zafran Meer |
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| DR-0028-24-P | 28/10/2024 | 28/10/2024 | Pharma | Minor | Shooters problem at T-700 compression machine | 4K175 | QAI has stopped the T-700 compression machine due to its shooters malfunctioning | N/A | N/A | Closed | | 02/11/2024 | | Zafran Meer | |
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| DR-0029-24-P | 11/11/2024 | 11/11/2024 | Pharma | Major | Punch jammed of Compression | 4L285 | Line clearance for Evokalm 200mg (Batch No. 4L285) was granted on compression machine ZP-37-B1. the initial sample was performed by Production and QAI. Just after during the operation of the machine, the punch became jammed. | | | Opened | | 13/11/2024 | | Zafran Meer | |
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| DR-0030-24-P | 14/11/2024 | 14/11/2024 | Pharma | Major | Less comulative yield observed at final packing stage in Avsar 80/5mg tablet | 4L234 | | | | | | 14/11/2024 | 25/11/2024 | Zafran Meer | Zafran Meer |
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| DR-0031-24-P | 06/12/2024 | 11/12/2024 | Pharma | | Difference in quantity of salmeterol Xinafoate for DPI in SAP BOM and picklist | 4N080 & 4N081 | During picklist review of Forsonide Cap. 250/50mcg and Forsonide Cap. 500/50mcg B.No 4N080 and 4N081 respectively, difference in quantity of salmeterol Xinafoate for DPI was observed.
Material Name Quantity Quantity in SAP BOM
salmeterol Xinafoate for DPI 14.500 gm
Quantity in Picklist
15.000gm
| RCA-0017-24 | CAPA-0029-24 | In Progress | | 11/12/2024 | | Hamza Ahmed | |