SOP List Small Volume Parenteral

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