QCS-019 - Quality Operations Procedures for Pharmaceutical, API, and Biotechnology - page 124

SOP No.:

Issued on:

Revision No.:

Initiator name:

(continu ed)

manufacturing, Qa (in-Process), and Qc documentation

s. no. documents dept. yes no n/a remarks

15. Sterile filtration integrity test printouts (before and after) Prod.

16. Vials/Ampoules sterilization and depyrogenation chart

(tunnel printout)

Prod.

17. Unusual interventions record Prod.

18. Ampoules leak test record Prod.

19. Ampoules terminal sterilization printout (if applicable) Prod.

20. Freeze dryer SIP and leak test printouts (if applicable) Prod.

21. Product freeze drying charts (if required) Prod.

22. Freeze vent filters integrity test printouts (if applicable) Prod.

23. Visual inspection report Prod.

24. Disinfectant preparation report Prod.

25. Temperature, RH, and differential pressure trend report Prod.

26. Process deviation reports (if any) Prod.

27. Checklist for bulk batch documents QA

28. Inspection start-up checklist with release label

(different stages)

QA

29. Bulk sampling reports QA

30. X bar and R control chart QA

31. QA visual inspection report QA

32. Documents compliance declaration QC

33. Analytical report for bulk product QC

34. Physical test reports on bulk solution (if applicable) QC

35. Density/weight determination reports (if applicable) QC

36. Liquid-borne particulate matter test report QC

37. Bulk release form QC

38. Environmental monitoring and personnel hygiene reports QC

39. Micro test reports for bioburden and endotoxin QC

Any other documents