Checklist for Audit in Sterile Area

Checklist to verify the sterile manufacturing area before the audit.
1. Is there any SOP giving details for activity/ movement in the sterile area.
2. Verify the suitability of the system for sanitization of hands.
3. Is there the SOP on entry-exit; gowning and de-gowning into the critical area available?
4. Verify the availability of the following records:

• Air pressure differential
• Particulate monitoring
• Temperature
• Humidity
• Microbiological monitoring by settle plate

5. Are these records available and maintained as per SOPs?

6. Check the above-mentioned individual records. Are the entries within specifications mentioned in SOP/ MTPs.
7. Is the controlled copy of MTP pertaining to monitoring by settle plate available to plant person?
8. Are the location for settle plates identified and the chart/ layout available with plant?
9. Are the following areas monitored for parameters mentioned in step 4:

• Air-lock to the critical area
• Critical area
• Controlled area
• Entrance in control area

10. Check the change room number 2 as per class?
11. Is there any environmental monitoring carried out in this area?
12. Is there any record maintained for cleaning in this area?
13. Check separate space specified and identification for fresh inner garment and used garment?
14. Check disinfectant solution must bear ‘use before’ label?
15. Is there any airlock between the class D area and the unclassified area?
16. Is there any interlocking provided to avoid contamination?
17. Is there any SOP to prepare the disinfectant solution in this area?
18. Is there any environmental monitoring carried out to maintain class D?
19. Is there any record maintained for monitoring the area at a particular frequency?
20. Is any microbiological monitoring carried out in this area?
21. Is any personnel monitoring carried out in class D?
22. If Yes- are the results recorded?
23. Is any cleaning record maintained for the class D area?
24. Is the cleaning procedure validated?
25. Is there any drainage sink in the class D area?
26. Is there any sop for sanitizing the sink, drainage?
27. Check the differential pressure of area is under specification limit
28. Check the door they must be closed automatically by pressure?
29. Is there any airlock provided between the unclassified area and class D area for receiving raw material?
30. Is there any interlocking provided in the airlock.
31. Is there any insectocutor outside the airlock?
32. Is there any air curtain outside the door?
33. Is there any sop to bring Al .container, sampling aid, rubber stopper from unclassified area to class D area?
34. Is there any sop for cleaning the container
35. Check the cracks, crevices, holes in the wall, ceiling floor.

36. Is there any sop for cleaning the sterilizer
37. Is there a record maintained for its operation
38. Is the adopted method for sterilization validated?
39. Check loading pattern displayed
40. Is any SOP prepared for cleaning the dry heat sterilizer?
41. Is there a loading pattern displayed
42. Is the adopted method for sterilization in DHS validated?
43. Is there any SOP for cleaning, sterilization for cartridge filter?
44. Is the adopted method for sterilization validated?
45. Is any computerized facility provided for sterilization?
46. Is computerized equipment validated?
47. Is there any pass box between the controlled area and the aseptic area?
48. Is there an SOP for handling the pass box?
49. Is adopting process validated for the pass box?
50. Is any environmental monitoring carried out for it?
51. Is any microbiological monitoring carried out and recorded?
52. Is there any record for UV light replacement in the pass box?
53. Check the differential pressure of various locations of the aseptic area. Are they under-specification?

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