QCS-019 - Quality Operations Procedures for Pharmaceutical, API, and Biotechnology - page 127

SOP No.:

Issued on:

Revision No.:

Initiator name:

(continued)

documents dept. yes no n/a remarks

18. Reconciliation form for leaflets Packaging

19. Reconciliation form for filled bottles/blisters/tubes/
supp/inhalers/sachets

Packaging

20. Area/equipment line clearance with cleaning status
labels

Packaging

Packaging

21. Line verification checklist signed by Eng. + Pack.
department for line no.—-

22. Output sheets (1st shift and 2nd shift) Packaging

23. Master packaging instructions (different consignees) Packaging

24. Packaging materials requisition (different
consignees)

Packaging

25. QC documents compliance declaration QC

26. Analytical report for bulk product (core in case of
tablet)

QC

27. Analytical report for bulk product (coating) QC

28. Bulk release form (core in case of tablet) QC

29. Bulk release form (coating) QC

30. Inspection of physical attributes (core) QC

31. Inspection of physical attributes (coating) QC

32. Bulk product checklist (core + coating) QA

33. QA inspection start-up checklist with release label
(bulk) (core + coating)

QA

34. QA in-process X & R chart QA

35. Filtration report for liquids Production

QA

36. QA sampling report (core + coating)

37. QA check master print outs QA

38. Production documents compliance declaration
(core + coating)

Production

39. Checklist for batch documents audit (core + coating) Production

40. Area equipment clearance with cleaning status labels Production

41. Drug weighing area/equipment clearance with
cleaning status labels

Weighing area

continued