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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 form?
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 taken?
b. sample size?
c. frequency of sampling?
d. test and specification including chemical and microbiological and pyrogen tests?

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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