Checklist for Audit in Liquid Production : Pharmaceutical Guidelines

Checklist for Audit in Liquid Production


Audit checklist for liquid products manufacturing facilities.
1. Is area cleaned and organized & free from unwanted materials?
2. Are the entry and gowning procedure followed as per SOP?
3. Is controlled copy of SOP’s displayed everywhere?
4. Is the particular disinfectant solution of the month is used for cleaning by given concentration as per SOP?
5. Are SOP’s & cleaning record available for each equipment?
6. Are doors closed and air circulation working?
7. Are containers & bags properly identified?
8. Are calibration & status labels on equipments?
9. Are containers of materials kept on pallets and properly identified and covered?

10 Is intactness of sieve & proper sieve number written?
11. Is the environmental status comply as per SOP.
12. Are bins cleaned and labeled?
13. Are manufacturing and storage tanks cleaned?
14. Is the filter press cleaned?
15. Are transfer pipelines and hose pipes cleaned?
16. Are transfer pumps and other utensils or containers cleaned?
17. Are return risers cleaned and their record maintained?
18. Are rinse or swab reports available?
19. Is the record of fumigation of area available?
20. Is preventive maintenance status available on equipments?
21. Are the equipment log books or relevant records completed up to current readings?
22. Are yields entered in each stage? Is area cleaned & organized & free from unwanted materials?
23. Are doors closed & air circulation working?
24. Is the washing machine cleaned?
25. Is area cleaned & organized & free from unwanted materials?
26. Is % yields of packed product recorded?
27. Are training records of personnel working is available?

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Ankur Choudhary is India's first professional pharmaceutical blogger, author and founder of Pharmaceutical Guidelines, a widely-read pharmaceutical blog since 2008. Sign-up for the free email updates for your daily dose of pharmaceutical tips.
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