CAAxxx of January'23 & February'23.pptx

Yes

1. CAPA of January’23 & February’23

2. Source of CAPA: Deviation Source Ref. No.: DEV/CPU-PRO/22/009 Description: During offline batch printing on catch cover for Famiclav 250 tablet (B/N:T3472076) printing error found (B/N:T3472054) on the catch cover by jet printer (Equipment ID:PR-147). CAPA Raising Date: 23-11-2022 S/N CAPA Reference No. Action to be completed Responsible Person Target Date Extended Date Current Status Remarks 01 CAPA/DEV/CPU-PRO/22/009/01 Off-line batch printing procedure needs to be introduced. Reaz Muhammad Pinon Sr. Executive 15-02-2023 Open Will be closed within timeline 02 CAPA/DEV/CPU-PRO/22/009/02 Printing head of jet printer needs to be cleaned once in day after last operation of a day that will be mentioned in Set up, operation and cleaning procedure of jet printing machine (SOP/CPU-PRO/058). Reaz Muhammad Pinon Sr. Executive 15-02-2023 Open

3. Source of CAPA : Customer Complaint Source Ref. No.: C.COM/CPU/22/001 Description: Inner bottle found without medicine of the Fix-A PFS 37.5 ml (B/N: P0142039) . CAPA Raising Date: 27-11-2022 S/N CAPA Reference No. Action to be completed Responsible Person Target Date Extended Date Current Status Remarks 01 CAPA/C.COM/CPU/22/001/01 Visual inspector list for bottle inspection must be prepared and displayed in the packaging line. Reaz Muhammad Pinon Sr. Executive 15-02-2023 Open Will be closed within timeline 02 CAPA/C.COM/CPU/22/001/04 SOP (Set up, Operation and Cleaning Procedure for Visual Inspection Line of Bottle, SOP/CPU-PRO/038) need to be updated with ‘’defect categorization appendix during each batch inspection”. Reaz Muhammad Pinon, Sr. Executive 15-01-2023 Open Closed

4. Source of CAPA: Quality Risk Management Source Ref. No.: QRM/CPU-QRMP/22/023 Description: Risk assessment on PFS (Powder for Suspension) filling and sealing process. CAPA Raising Date: 31-10-2022 S/N CAPA Reference No. Action to be completed Responsible Person Target Date Extended Date Current Status Remarks 01 CAPA/ QRM/ CPU-QRMP/22/023/01 Primary batch document (BPR) of the PFS products need to be updated with including- • yield calculation. Reaz Mohammad Pinon Sr. Executive 02-02-2023 Open Will be closed within timeline

5. Source of CAPA: OOS Source Ref. No.: OOS/CPU/QC/21/004 Description: Related substance of Fix-A PFS 75 ml (Batch No.: P0341011) stability sample after 6 months in IVB condition; Related substance of Fix-A PFS 100 ml (Batch No.: P0381001, P0381002, P0381003, P0381004) stability samples after 3 months in accelerated and IVB condition were found out of specification. CAPA Raising Date: 24-01-2022 S/N CAPA Reference No. Action to be completed Responsible Person Target Date Extended Date Current Status Remarks 01 CAPA/OOS/CPU/QC/21/004/02 Analytical method for related substance of Cefixime for oral suspension as need to be validated according to proposed USP in-process revision. Md. Shimul Islam, Sr. Executive 28-09-2022 31-03-2023 Open Will be complete within timeline

6. Source of CAPA: OOS Source Ref. No.: OOS/CPU/QC/22/018 Description: Assay found out of specification during testing the 9 months long term condition (IVB) sample of Famiclav PFS 70 ml (B/N: P0392001, P0392002, P0392003 & P0392004). Specification: Clavulanic Acid: (25.0-37.0) mg, Initial Result: P0392001 (4.72mg), P0392002 (27.88 mg), P0392003 (30.29 mg) & P0392004 (13.42 mg). CAPA Raising Date: 18-12-2022 S/N CAPA Reference No. Action to be completed Responsible Person Target Date Extended Date Current Status Remarks 01 CAPA/OOS/CPU/QC/22/018/02 Stability study protocol (PO, PV & ongoing stability study) need to be updated including zone IVA (300C±20C & 65±5%RH) for ongoing stability and condition (250C±20C & 60±5%RH) for intermediate stability study. Md. Monjil Hossain, Sr. Executive 31-01-2023 Open Will be complete within timeline

7. Source of CAPA :Surveillance Audit Source Ref. No .: QS/CPU-QC/062-22 Description: As per SOP of data backup, archive restore and disaster management for standalone instrument (SOP/CPU-QC/124); In subsection (8.10) it has been mentioned that; perform the backup verification record twice in a year but data verification record was not prepared yet. Although SOP has been effective on 08/05/22 CAPA Raising Date: 15-11-2022 S/N CAPA Reference No. Action to be completed Responsible Person Target Date Extended Date Current Status Remarks 01 CAPA/QS/ CPU-QC/062-22/03 Backup verification will be performed through Appendix- D (Backup data restoration Form) of SOP (SOP/CPU-QC/124) Mohabbat Ullah Manager and M.A.G Shamsuzzoha Chowdhury, Sr. Executive 30-02-2023 Open Will be complete within January

8. Source of CAPA : LIR Source Ref. No .: LIR/CPU/22/0013 Description: During Residue determination analysis of Fulspec 1g IV injection (B/N: V0462005) the sequence was suddenly stopped due to an error occurred on the analytical instrument (QC-EQ-077). CAPA Raising Date: 12-06-2022 S/N CAPA Reference No. Action to be completed Responsible Person Target Date Extended Date Current Status Remarks 01 CAPA/LIR/ CPU/22/ 0013/01 A routine maintenance with the supplier or user need to be ensured in future to avoid this type of incident. Obydulla, Execuitive 31-12-2022 15-02-2023 Open Will be complete within January during EPM

9. Source of CAPA : Change Control Source Ref. No.: CCR/CPU-SBMD/22/004 Description: Auto vial label of all injectable products need to be printed with red color. CAPA Raising Date: 29-08-2022 S/N CAPA Reference No. Action to be completed Responsible Person Target Date Extended Date Current Status Remarks 01 CAPA/CCR/CPU-SBMD/22/004/01 Auto vial label of all injectable products (list attached) need to be developed with necessary changes and approved. Sharmin Sultana, Dty . Manager & N. A. M Akter Jahid , Asst. Manager 28-02-2023 Open All product s are complete accept Trizidim

10. Source of CAPA :Surveillance Audit Source Ref. No .: QS/CPU-PRO/040-22 Description: The qualification was not performed for the de dusting/Air shower channel used for material receiving or returning. CAPA Raising Date: 27-07-2022 S/N CAPA Reference No. Action to be completed Responsible Person Target Date Extended Date Current Status Remarks 01 CAPA/ QS/CPU-PRO/040-22/03 Performance qualification of de duster/Air shower will be performed. Shah Jafar Al Fatah Asst. Manager, 28-02-2023 Open Will be complete within timeline

11. Source of CAPA : Change Control Source Ref. No.: CCR/CPU-MIC/22/004 Description: Installation of a new double door autoclave in place of existing one (ID: QC-EQ-046) in CPU Microbiology laboratory. CAPA Raising Date: 04-09-2022 S/N CAPA Reference No. Action to be completed Responsible Person Target Date Extended Date Current Status Remarks 01 CAPA/CCR/CPU-MIC/22/ 004/05 Qualification (IQ, OQ & PQ) need to be performed for double door autoclave. Md. Jaed Hasan, Executive 31-01-2023 Open Need to be Extend 02 CAPA/CCR/CPU-MIC/22/ 004/07 Calibration schedule needs to be updated including new double door autoclave and excluding double door autoclave (ID: QC-EQ-046). Md. Masud Rana, Asst. Engineer 30-01-2023 Open