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List of SOP for Quality Assurance in Pharmaceutical Industry

The development and use of SOPs are an integral part of a pharmaceutical quality system as it provides individuals with the information to perform the job properly, and facilitates consistency in the quality and integrity of a product or process.

1. SOP for SOP

2. SOP for Good documentation practices

3. SOP for Signature Log

4. SOP for Documentation control and Management

5. SOP for Change control procedure

6. SOP for Archive, storage, retrieval and disposal of records

7. SOP for Preparation, Review,  Approval and Distribution of 'Standard Operating Procedure' ;'Equipment Operating Procedure' and 'Equipment Calibration Procedure'

8. SOP for Control and Issuance of Logbooks

9. SOP for SOP for Process Validation

10. SOP for Code Numbering system of Forms and Status Label 

11. SOP for Quality Risk Management

12. SOP for Procedure for Corrective Actions and Preventive Actions (CAPAs) Management

13. SOP for Training of New and Existing Employees

14. SOP for Personnel hygiene and usage of personnel protective equipment

15. SOP for Procedure for Vendor Qualification

16. SOP for Self-Inspection/ Internal Audit

17. SOP for Procedure for product batch number Issuing & Handling of BMR & BPR 

18. SOP for Carrying out IPC, AQL and handling of IPC parameters/ AQL failure during manufacturing

19. SOP for In-process Check & Handling of IPC Parameters Failure during packaging

20. SOP for Temperature, Humidity and Differential Air Pressure monitoring

21. SOP for Quality Incident Report

22. SOP for Review of batch records and Release for Packaging 

23. SOP for Release of finished products

24. SOP for Preparation and Reconciliation of Passed and Released Label 

25. SOP for Handling of materials for rejection and destruction

26. SOP for Handling of TSE/BSE Certification

27. SOP for Assign Retest of bulk product and Manufacturing and Expiration Date of Product

28. SOP for Use and control of hand sanitizer

29. SOP for Shipping of finished product for export

30. SOP for Annual Product quality review

31. SOP for Investigating and analyzing customer complaints

32. SOP for Product Recall

33. SOP for Handling of returned goods and salvaging of drug products

34. SOP for Preparation for GMP Inspection

35. SOP for Issuance and Control of Product Identification Number, NDC, Pharma code, GTIN-14, BAR code and GLN

36. SOP for Procedure for qualification of contract testing laboratories 

37. SOP for Procedure for reprocess /rework

38. SOP for Change control procedure for SAP

39. SOP for SAP Security and Authorization Issue

40. SOP for Backup and Restore procedure for SAP

41. SOP for Operational Management procedure for SAP

42. SOP for Business Continuity Program and Disaster Management

43. SOP for Business Continuity Program and Disaster Management procedure for SAP

44. SOP for Preparation and Approval  of Quality manual

45. SOP for Handling of  deviation

46. SOP for In-process check & handling of IPC parameters failure during manufacturing

47. SOP for Execution of Quality Review Meeting

48. SOP for Handling of material transfer from one code to another

49. SOP for Procedure for root cause analysis

50. SOP for Review of batch records (BMR & BPR) and Release for Packing

51. SOP for Product recall for USA market 

52. SOP for Access control, security policies and user management

53. SOP for Procedure For Quality Metrics

54. SOP for Preparation Review And Approval of Site Master File

55. SOP for Procedure for Vendor Audit

56. SOP for Good Distribution Practices of Finished Products

57. SOP for Procedure for preparation of  Agreements

58. SOP for Shredding Of Documents

59. SOP for Procedure For Handling of GR Cancellation

60. SOP for Access control of users and user level security for PLC/ HMI based equipment

61. SOP for Prevention of contamination and cross-contamination in Production area

62. SOP for Handling of Regulatory guideline and Compendia Updates / Changes

63. SOP for SAP ERP data Archiving Procedure

64. SOP for Quality Assurance Oversight Activity

65. SOP for Procedure For Allocating Global Location Number (GLN)

66. SOP for Sampling of Powders, Granules, Bulk product & Finished products

67. SOP for Data Integrity and Handling of Violations / Breach of Data Integrity

68. SOP for Access control, user management and authorization issue in software system

69. SOP for Procedure for procurement of machine, Equipment, Instrument and system

70. SOP for Access control  procedure for GMP area

71. SOP for Procedure for Timeline Extension

72. SOP for Execution of quality management review meeting

73. SOP for Procedure for Continual Improvement

74. SOP for Handling and Reporting of Adverse Drug Reaction Information

75. SOP for Force release of Finished Product of water for injection 

76. SOP for Procedure for Reviewing of External Certificates / Documents

77. SOP for Procedure for Generation of Addendum of Approved Documents

78. SOP for Procedure for cleaning of sample container

79. SOP for Startup approval of manufacturing & packaging operation

80. SOP for Procedure for Shelf life extension of products

81. SOP for Sampling of bulk, Filled and Finished product

82. SOP for Procedure for Disaster Management and Business continuity plan

83. SOP for Cleaning of unit dose tablet maker & unit dose sampling thief

84. SOP for Cleaning of miniature SS container for hold time study sampling


Tags in: quality assurance SOP, SOP for QA, list of SOP for pharmaceutical QA.

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