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List of Sop-Qa

LIST OF SOP-QA

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180 views3 pages

List of Sop-Qa

LIST OF SOP-QA

Uploaded by

Nishat Mim
Copyright
© © All Rights Reserved
We take content rights seriously. If you suspect this is your content, claim it here.
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Download as DOCX, PDF, TXT or read online on Scribd
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C2C PHARMA LTD.

Gorat, Yearpur, Ashulia, Dhaka-


1341

List of Standard Operating Procedure

Department Quality Assurance Document L/SOP/QA/01

Name: No.

SL SOP Title Document Effective Review

No. No. Date Date

1. SOP for SOP SOP/QA/ 07-Feb-2024 06-Feb-2027


001/04

2. GMP Documents and Records SOP/QA/ 05-Dec-2023 04-Dec-2026


Management 002/01

3. Vendor Qualification for Raw & SOP/QA/ 27-Nov-2024 26-Nov-2027


Packaging Materials 003/00

4. Batch Numbering and Batch SOP/QA/ 14-Dec-2023 13-Dec-2026


Coding Procedure 004/01

5. Change Control SOP/QA/ 10-Dec-2024 09-Dec-2027


005/05

6. Training Management SOP/QA/ 05-Dec-2024 04-Dec-2027


006/02

7. SOP for Equipment/Machine SOP/QA/ 04/12/2021 01/12/2024


Identification (ID) Number 007/00

8. SOP for Thermal Mapping SOP/QA/ 09-Jul-2024 08-Jul-2027


008/01
9. Quality Risk Management SOP/QA/ 19-Dec-2023 18-Dec-2026
009/01

10. Acceptable Quality Level SOP/QA/ 29-Jun-2024 28-Jun-2027


Management 010/01

11. Deviation Management SOP/QA/ 05-Dec-2024 04-Dec-2027


011/02

12. Preparation, Review and SOP/QA/ 27-Jan -2024 26-Jan-2027


Approval of Site Master File 012/01

13. SOP for Preparation of SOP/QA/ 17-Oct-2024 16-Oct-2027


Validation Master Plan 013/01

Template No.: T/SOP/QA/001/02/00 Page 1 of 3


14. Qualification of Facility, Utilities SOP/QA/ 18-Sep-2023 17-Sep-2026
and Equipment’s 014/02

15. Recall Management SOP/QA/ 23-Mar-2024 22-Mar-2027


015/00

16. Quality Audit Management SOP/QA/ 31-Jan-2024 30-Jan-2027


016/00
17. Product Quality Review SOP/QA/ 02-Apr-2024 01-Apr-2027
017/00
18. Corrective Action and SOP/QA/ 19-Dec-2023 18-Dec-2026
Preventive Action Management 018/01

19. Code Numbering System of Raw SOP/QA/ 15-Dec-2023 14-Dec-2026


Material, Products & Packaging 019/02
Material
20. Retention Sample Management SOP/QA/ 28-Nov-2024 27-Nov-2027
020/01

21. Quality Management System SOP/QA/ 08-Jul-2024 07-Jul-2027


021/00

22. Calculations and Rounding off SOP/QA/ 30-Jun-2024 29-Jun-2027


Significant Figures 022/00

23. Management of Contract SOP/QA/ 20-Aug-2024 19-Aug-2027


Manufacturing Site 023/00

24. Batch Record Review and Batch SOP/QA/ 01-Sep-2024 31-Aug-2027


disposition 028/02

25. SOP for Line Clearence SOP/QA/ 20-Dec-2023 19-Dec-2026


029/01

26. SOP for Control, Issue & SOP/QA/ 13-Nov-2022 12-Nov-2025


Distribution of Status Labels 031/00

27. In Process Control for SOP/QA/ 20-Mar-2024 19-Mar-2027


Manufacturing and Packaging of 039/01
Pharmaceutical Products.
28. Self-Inspection SOP/QA/ 12-Jun-2024 11-Jun-2027
048/02

29. Logbook Management SOP/QA/ 14-Jan-2024 13-Jan-2027


052/01
30. Customer Complaint SOP/QA/ 20-Feb-2024 19-Feb-2027
Management 057/01
31. Returned Products Management SOP/QA/ 20-Feb-2024 19-Feb-2027
058/01
32. SOP for Calibration Guideline of SOP/QA/ 11/12/2022 10/12/2025
Equipment 063/00

33. SOP for Operation, Cleaning and SOP/QA/ 10-Mar-2024 09-Mar-2027


Calibration of Disintegration 065/01
Tester

Template No.: T/SOP/QA/001/02/00 Page 2 of 3


34. SOP for Operation, Cleaning, SOP/QA/ 14-Mar-2024 13-Mar-2027
Calibration of Friability Tester 066/01

35. Operation, Cleaning, Accuracy SOP/QA/ 23-Jun-2024 22-Jun-2027


Checking and Calibration of 067/02
Electronic Weighing Balance
36. SOP for Operation, Cleaning and SOP/QA/ 29-Feb-2024 28-Feb-2027
Calibration of Hardness Tester 068/01
(TBF 100i)
37. SOP for Slide Calipers SOP/QA/ 29-Feb-2024 28-Feb-2027
069/01

38. SOP for Operation, Cleaning and SOP/QA/ 29-Feb-2024 28-Feb-2027


Calibration of Leak Test 070/01
Apparatus
39. SOP for Moisture Analyzer SOP/QA/ 24-Jun-2024 23-Jun-2027

071/01

Revision History

Version Reason for Revision

No.

01 New & Updated SOP Included

00 First Document

Name Designation Signature Date

Prepared Yesmin Akter Tonny Officer, Quality


Assurance
by

Checked Mohammed Raihan Head of Quality


Chowdhury Assurance
by

Template No.: T/SOP/QA/001/02/00 Page 3 of 3

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