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
Related:
- List of SOP for Pharmaceutical Industry
- List of SOP for Pharmaceutical Production
- List of SOP for Quality Control Laboratory
