Important SOPs for Quality Control Department (Chemical section) in Pharmaceutical Industry


  1. Sampling of raw material, packaging material, bulk, intermediate and finished product
  2. Raw material, packaging material, bulk, intermediate and finished product analysis
  3. Cleaning and storage of sampling equipment
  4. Preparation of specifications
  5. Procurement of laboratory chemicals
  6. Collection, retention and destruction of reference and retention samples
  7. Procurement, handling and storage of reference standards
  8. Preparation, handling and storage of working standards
  9. Cleaning of laboratory glassware and accessories
  10. Calibration of laboratory glassware
  11. Preparation and standardization of volumetric solution
  12. Sampling and analysis of purified water
  13. Labelling of reagents and chemicals
  14. Rinse water analysis
  15. Cleaning, operation and calibration of balances
  16. Operation and calibration of polarimeter
  17. Operation and calibration of Karl Fischer auto-titrator
  18. Operation and calibration of pH meter
  19. Operation and calibration of melting point apparatus
  20. Operation and calibration of vacuum oven
  21. Operation and calibration of refractometer
  22. Operation and calibration of UV-VIS spectrophotometer
  23. Operation and calibration of HPLC
  24. Operation and calibration of Vernier
  25. Handling of quality control note book, logs and work sheets
  26. Preparation of buffer solution
  27. Handling and management of HPLC columns
  28. Calibration of UV cabinet
  29. Operation and calibration of bursting strength apparatus
  30. SOP on analytical method validation
  31. SOP on analytical method verification
  32. SOP on analytical method transfer
  33. Operation of hot plate
  34. SOP on Good Laboratory practices
  35. Preparation of specifications
  36. SOP on out of specification
  37. Handling of instrument breakdown
  38. SOP on operation and calibration of dissolution apparatus
  39. Temperature mapping of stability chamber
  40. Operation and maintenance of stability chamber
  41. Temperature mapping of refrigerators
  42. Handling of hazardous substances in QC laboratory
  43. SOP on retesting of raw materials
  44. SOP on handling laboratory incident
  45. Calibration and validation schedule of QC instruments
  46. Calibration of temperature monitoring devices
  47. Preparation of certificate of analysis
  48. Handling of laboratory waste materials
  49. Operation and calibration of IR spectroscopy
  50. Operation and calibration of Gas chromatography
  51. Qualification of QC chemist

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