Important SOPs for Quality Assurance in Pharmaceutical Industry

1. Preparation, review, approval and control of SOPs
2. Training procedure
3. Handling and control of documents
4. Change control
5. Handling of deviations
6. SOP for line clearance
7. Handling of market complaint
8. Preparation, approval and control of master batch documents
9. Issuance and control of batch manufacturing documents
10. SOP for batch numbering policy
11. Sampling procedure
12. Batch release procedure
13. Preparation, review and control of site master file
14. Product recall
15. Handling of returned and rejected goods
16. Self-inspection programme
17. Product quality review
18. Quality risk management
19. Visual inspection of finished product
20. Corrective and preventive actions
21. Cleaning validation
22. Process validation
23. Good distribution practices
24. Vendor qualification and management
25. Issuance and maintenance of equipment and instrument logs
26. Process simulation study/Media fill
27. Hold time study
28. Validation master plan
29. SOP of handling regulatory and external audits
30. SOP for environmental monitoring
31. Access control in production facility
32. Good documentation practices
33. Facility shut down and start up
34. Numbering system of equipment/instruments
35. Qualification of equipment/instrument
36. Document archival, retention and destruction
37. Expiry date assigning policy of finished product
38. Management of reference/retention samples
39. Stability study
40. Job responsibilities of employee
41. Qualification of computerized system
42. In process checks
43. Handling of hazardous materials
44. Entry and exit procedure in production and microbiology area
45. Rounding off and interpretation of results
46. Technical agreements
47. Self hygiene
48. Handling of typographical errors in documents
49. SOP for temperature mapping
50. SOP for data integrity

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