QUALITY ASSURANCES

SOP LIST OF QUALITY ASSURANCES

  1. Preparation, Approval and Control of Standard Operating Procedures
  2. Internal Audit and Self Inspection
  3. Handling of Product Complaints
  4. Product Recall and Handling of Recalled Products
  5. Batch Numbering
  6. Preparation, Approval and Control of Technical Directions for Bulk Drug Preparation.
  7. Issue of Batch Manufacturing Records for Contract Manufacturing Locations
  8. Assigning Manufacturing and Expiry dates to the Finished Products
  9. Annual Product Review
  10. Correction of Documentation Errors
  11. Control of Master Formula Records (MFRs)
  12. Disposal of Expired or Obsolete Raw Materials
  13. New Product Design and Development Process
  14. Preparation, Approval, Review and Control of Operating Guidelines
  15. Preparation, Approval, Control and Distribution of General Test Procedures
  16. Review of Batch Manufacturing Record
  17. Release of Finished Goods
  18. Assigning of Numbers for Qualification Documents, Validation Protocols and Reports
  19. Assessment of Contract Analytical Laboratory for Qualification
  20. Document and Data Control
  21. Date and Time Format in Written Procedures
  22. Corrective and Preventive Action
  23. Quality management
  24. Utilization of BOPP tapes
  25. Art work Designing and Approval
  26. Management of Clinical Supplies
  27. Preparation and Handling of Un-blinding Envelopes
  28. Training Procedures
  29. Certification of trainer
  30. Preparation, Approval and control of corporate manuals
  31. Product Quality Review
  32. Management of Equipment
  33. Issue, Receipt, Storage and Destruction of Batch Manufacturing Records
  34. In-process Checks during Packaging Operations
  35. Review of Batch Manufacturing Record
  36. In process Checks by IPQA
  37. Sampling of In process Materials and Finished Products
  38. Qualification procedure for External Calibrating Agency
  39. Handling of Out-of-Specification and Out-of Trend Test Results
  40. Sampling of Wash Water
  41. Storage, Handling and Destruction of Control Samples of Finished Products
  42. Release of Clinical Trial batch(s) for further Repacking and Testing
  43. In-Process and Finished Goods Testing
  44. Testing of Primary Packaging Materials
  45. Batch Numbering procedure for Optimization /Exhibit Batches of Drug Products and Intermediates
  46. Procedure for Procurement, Handling, Storage and Reconciliation of LDPE Polybags and Hand Gloves
  47. Planning and Handling of Exhibit batches and Placebo batches
  48. Analytical Requisition Numbering Procedure for In-process, Finished Product and Wash Water Sample
  49. Blinding and Re-labeling of Clinical Trial Samples for Clinical Trial purpose
  50. Issuance and Control of Formats /Records / Log Books.
  51. Cleaning Procedure for Sampling Aids
  52. Handling of Yield Non-conformance
  53. SOP on Cleaning Program
  54. Destruction of Placebo Batches
  55. Handling of Incidents
  56. Recording observations in Batch manufacturing records
  57. Repackaging / Re-labeling of Finished Goods
  58. Recording of Specimen Signatures
  59. Procedure for Operation of SAP system in Quality Assurance Department
  60. Electronic data backup management system
  61. Code to Code Transfer of Materials and Additional Testing of Materials / Products
  62. Access control system numbering and usage
  63. Preparation of Validation and Qualification protocols
  64. Control of Stamps in Quality Assurance Department
  65. Assigning of Identification Numbers to Equipments, Sub-Equipments and In-process SS Items
  66. Assigning Master Formula Card Number, Master Formula Number and Packaging Formula Number to the Drug Products
  67. SOP for Assigning of Numbers for Qualification Documents, Protocols and Reports
  68. Line Clearance
  69. Numbering of compactor and Storage of documents in the compactor system of Documentation cell-QA.
  70. Safety Manual “Permit System”