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Checklist For Audit in Sterile Area - Pharmaceutical Guidelines
Checklist For Audit in Sterile Area - Pharmaceutical Guidelines
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1. Is there any SOP giving details for activity/ movement in the sterile area.
3. Is there the SOP on entry-exit; gowning and de-gowning into the critical area available?
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?
13. Check separate space specified and identification for fresh inner garment and used garment?
15. Is there any airlock between the class D area and the unclassified area?
17. Is there any SOP to prepare the disinfectant solution in this area?
19. Is there any record maintained for monitoring the area at a particular frequency?
29. Is there any airlock provided between the unclassified area and class D area for receiving raw material?
33. Is there any sop to bring Al .container, sampling aid, rubber stopper from unclassified area to class D area?
35. Check the cracks, crevices, holes in the wall, ceiling floor.
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10/4/21, 5:48 PM Checklist for Audit in Sterile Area : Pharmaceutical Guidelines
40. Is any SOP prepared for cleaning the dry heat sterilizer?
43. Is there any SOP for cleaning, sterilization for cartridge filter?
47. Is there any pass box between the controlled area and the aseptic area?
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?
Ankur Choudhary is India's first professional pharmaceutical blogger, author and founder of Pharmaceutical Guidelines, a widely-read pharmaceutical blog
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