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 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?

Also see: Chemical Sanitization of RO Systems and Biofilm Removal

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