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GMP Audit Check List- Water Supply System

GMP audit checklist for water supply system in manufacturing of pharmaceutical products.
•  To ensure the reliable production of water of the required quality are water treatment plants -
A. designed and constructed?    B. maintained and operated?.
•  Are water sources, water treatment equipment and treated water checked for contamination and maintained regularly for
A. chemical?  B.  Microbial?
•  Does the monitoring system cover
a. sample size?
b. location where samples are taken from?
c. frequency of sampling?
d. test and specifications including chemical, microbiological and Pyrogen tests?

•  Are records of the result of the monitoring and any of remedial action maintained?
•  Is the water produced, stored and distributed in such a way to discourage microbial growth?
•  Are pressure relief outlets of water storage protected by hydrophobic microbial air filters?
•  Method of water for production;
a. by distillation? b. by other means (mention the method)? ... ...
•  Is purified /Distilled water stored
a. in clean, non-reactive, non-absorptive, non-additive containers?
b. protected from contamination?
•  If it is not recirculated, is it discarded after 24 hours?
•  Is UV light installed in purified water distribution system?
•  Is there a sampling procedure covering
a. location where samples were taken?
b. sample size?
c. frequency of sampling?
d. test and specification including chemical and microbiological and pyrogen tests?

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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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