GMP Audit Check List- water supply system
To ensure the reliable production of water of the required quality are water treatment plants -A. designed and constructed? B. maintained? 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 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 perogen tests?
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