RE: RE: validation of purified water system Contribution from A.v.Wijk written on 3/22/2006 at 08:57
Original contribution: RE: validation of purified water system written by Dick Bonner on 3/15/2006 at 19:42) Thank you for your reply. We found in FDA guidelines that the minimum requirement for validation is 2-4 weeks. The issue raised is the following: Our QC performs reduced alalyses on the points of use. The intention of the PWS is to comply to GMP(EP) but also to FDA (USP). Is it necessary to analyse fully acc. to EP/USP or is our reduced testing enough acc. to our internal spec? Is it also allowed when e.g. heavy metals result acc. to EP also can be resulted as a USP result if the result is within spec?
Are there any rules or statements of these mentioned items and where can i find them? Answers to this contribution:
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