MAVERICKS ASSOCIATION

SOP List Small Volume Parenteral

—

by

Alvina
in

SOP List Small Volume Parenteral

  1. General planning and works instruction in production
  2. Entry & Exit Procedure for Clean Area Manufacturing Room
  3. Entry & Exit Procedure for Clean Area Filling Room
  4. Clean & Sanitization of Classified/Clean area
  5. Procedure for Packing Material Reconciliation and its Destruction 
  6. Area cleaning and Sanitization
  7. Disinfectant  solution preparation, consumption & Destruction for SVP Section
  8. SOP for resuming the aseptic area after maintenance activities.
  9. Monitoring of temperature/ Humidity, differential pressure & air born non-viable particle count (SVP Section)
  10. Clean room behavior & personal hygiene
  11. Batch Preparation of SVP products
  12. CIP & SIP of Manufacturing Tank, Holding, Product line, Filter assembly & FFS Machine
  13. Handling of terminally sterilized (Ampoules) & aseptically filled & sealed SVP Container (Respules)
  14. Filter Integrity of Product/ Hydrophilic Filter
  15. Filter Integrity of Hydrophobic/ Vent Filter
  16. Disposal of waste/ Scrap materials
  17. Filter Management
  18. Clean area footwear cleaning & sanitization
  19. In – Process check during various manufacturing stage in the SVP section
  20. Charging of Plastic granules
  21. Training of new visual inspector
  22. Handling of Non-Sterilized Filled & Sealed Vials/Ampoules
  23. SOP for washing & inspection of clean area garments
  24. SOP  for Media Fill/ Process Simulation Validation
  25. Management of sterile area after power resumes 
  26. Classified Area  Entry & Exit Procedure
  27. Entry & Exit procedure for the unclassified area of SVP Section
  28. Calibration of SVP Manufacturing/ Holding vessel(300 liter & 500 liter )
  29. Cleaning & decontamination after media fill
  30. Transfer of dispensed raw material in the manufacturing area
  31. SOP for Handling & Storage Packing Material for SVP section
  32. Operation of filter Integrity test Instrument 
  33. Cleaning, Operation & Monitoring of HPHV Steam Sterilizer
  34. Cleaning, Operation, Monitoring  & Mould change procedure of FFS Machine
  35. Cleaning, Operation & monitoring  of Superheated Water spray sterilizer
  36. Cleaning & Operation of Visual Inspection Table of SVP Section.
  37. Cleaning, Operation & Monitoring of Sticker Labeling Machine
  38. Operation & Calibration of Conductivity Meter
  39. Cleaning, Operation &  Monitoring of Mobile LAF Trolley
  40. Operation & Calibration of pH meter
  41. Cleaning, Operation &  Monitoring of Dynamic Pass box
  42. Cleaning, operation & Monitoring of vertical LAF of the SVP section
  43. Cleaning, operation & Monitoring of Dynamic garment cubical of SVP Section
  44. Cleaning, Monitoring  & Operation procedure for Holding tank & Manufacturing tank                      
  45. Fogging in SVP Section
  46. SOP for operation & Cleaning of Garment Washing Machine
  47. Cleaning of Plastic Crates
  48. Cleaning and Operation of Vacuum cleaner for the SVP section
  49. Cleaning and Operation of three bucket trolley system
  50. Operation & Cleaning of Non-Viable particle count
  51. Cleaning, Operation & Monitoring and Challenge of Vacuum Leak Test Machine