Pharmaceutical Guidance Complete Pharma Solution
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. |
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
