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SOP LIST (Quality Assurance)

SOP LIST (Quality Assurance)

S. No. SOP Title
1.        Preparation, Approval, and Control of Standard Operating Procedures
2.        Vendor Approval
3. Change Control
4. Preparation, Approval, Review and Control of Technical Directions for Manufacture of Drug Products.
5. Preparation, Approval and Control of Specifications and Standard Test Procedures for Raw Materials, Packaging Materials, In-process Materials and Finished Products
6. Internal Audit and Self Inspection
7. Handling of Product Complaints
8. Product Recall and Handling of Recalled Products
9. Batch Numbering
10. Preparation, Approval and Control of Technical Directions for Bulk Drug Preparation.
11. Issue of Batch Manufacturing Records for Contract Manufacturing Locations
12. Assigning Manufacturing and Expiry dates to the Finished Products
13. Annual Product Review
14. Correction of Documentation Errors
15. Batch Numbering System at Contract Manufacturing Locations
16. Control of Master Formula Records (MFRs)
17. Disposal of Expired or Obsolete Raw Materials
18. New Product Design and Development Process
19. Preparation, Approval, Review and Control of Operating Guidelines
20. Preparation, Approval, Control and Distribution of General Test Procedures
21. Review of Batch Manufacturing Record
22. Release of Finished Goods
23. Assigning of Numbers for Qualification Documents, Validation Protocols and Reports
24. Assessment of Contract Analytical Laboratory for Qualification
25. Sampling and Analysis of Ground Water and Drinking Water
26. Document and Data Control
27. Assigning Master Formula Card Number, Master Formula Number and Packaging Formula Number to the Drug Products
28. Date and Time Format in Written Procedures
29. Handling of Non-Conformances
30. Handling of Deviations
31. Corrective and Preventive Action
32. Quality management
33. Utilization of BOPP tapes
34. Art work Designing and Approval
35. Management of Clinical Supplies
36. Preparation and Handling of Un-blinding Envelopes
37. Training Procedures
38. Certification of trainer
39.  Preparation , Approval and control of corporate manuals
40. Assigning of Identification Numbers to Equipments, Sub-Equipments and In-process SS items
41. Management of Equipment
42. Issue, Receipt, Storage and Destruction of Batch Manufacturing Records
43. In-process Checks during Packaging Operations
44. Review of Batch Manufacturing Record
45. In-process Checks by IPQA
46. Sampling of In process Materials and Finished Products
47. Qualification procedure for External Calibrating Agency
48. Handling of Out-of-Specification and Out-of Trend Test Results
49. Line Clearance
50. Sampling of Wash Water
51. Storage, Handling and Destruction of Control samples of finished Products
52. Release of Clinical Trial Batch(s) for further Repacking and Testing
53. In-process and finished goods Testing
54. Testing of Primary Packaging Materials
55. Batch Numbering procedure for Optimization Batches of Drug Products and Intermediates
56. Planning & Handling of  Placebo and Exhibit batches
57. Analytical Requisition Numbering procedure for in process, Finish product & wash water Samples
58. Blinding and Re-labeling of Clinical Trial Samples for Clinical Trial Purpose
59. Issuance and Control of Formats/ Records / Log Books
60. Cleaning procedure for Sampling Aids
61. Cleaning Program
62. Destruction of Placebo Batches
63. Handling of Incidents
64. Recording observations in BMRs.
65. Repackaging /Relabelling of returned goods
66. Recording of specimen signatures
67. Preparation, approval and control of computer system validation
68. Operation release of finished goods from Quality Assurance department in SAP system
69. Electronic data backup management   system
70. Code transfer of materials and additional testing of materials/ products.

 

About Pharmaceutical Guidanace

Mr. Shiv Kumar is the Author and founder of pharmaceutical guidance, he is a pharmaceutical Professional from India having more than 14 years of rich experience in pharmaceutical field. During his career, he work in quality assurance department with multinational company’s i.e Zydus Cadila Ltd, Unichem Laboratories Ltd, Indoco remedies Ltd, Panacea Biotec Ltd, Nectar life Science Ltd. During his experience, he face may regulatory Audit i.e. USFDA, MHRA, ANVISA, MCC, TGA, EU –GMP, WHO –Geneva, ISO 9001-2008 and many ROW Regularities Audit i.e.Uganda,Kenya, Tanzania, Zimbabwe. He is currently leading a regulatory pharmaceutical company as a head Quality. You can join him by Email, Facebook, Google+, Twitter and YouTube

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