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. |