Quality

  1. Preparation, review, approval and control of SOPs
  2. Training procedure
  3. Handling and control of documents
  4. Change control
  5. Handling of deviations
  6. SOP for line clearance
  7. Handling of market complaint
  8. Preparation, approval and control of master batch documents
  9. Issuance and control of batch manufacturing documents
  10. SOP for batch numbering policy
  11. Sampling procedure
  12. Batch release procedure
  13. Preparation, review and control of site master file
  14. Product recall
  15. Handling of returned and rejected goods
  16. Self-inspection programme
  17. Product quality review
  18. Quality risk management
  19. Visual inspection of finished product
  20. Corrective and preventive actions
  21. Cleaning validation
  22. Process validation
  23. Good distribution practices
  24. Vendor qualification and management
  25. Issuance and maintenance of equipment and instrument logs
  26. Process simulation study/Media fill
  27. Hold time study
  28. Validation master plan
  29. SOP of handling regulatory and external audits
  30. SOP for environmental monitoring
  31. Access control in production facility
  32. Good documentation practices
  33. Facility shut down and start up
  34. Numbering system of equipment/instruments
  35. Qualification of equipment/instrument
  36. Document archival, retention and destruction
  37. Expiry date assigning policy of finished product
  38. Management of reference/retention samples
  39. Stability study
  40. Job responsibilities of employee
  41. Qualification of computerized system
  42. In process checks
  43. Handling of hazardous materials
  44. Entry and exit procedure in production and microbiology area
  45. Rounding off and interpretation of results
  46. Technical agreements
  47. Self hygiene
  48. Handling of typographical errors in documents
  49. SOP for temperature mapping
  50. SOP for data integrity

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