RE: RE: RE: validation of purified water system Contribution from Dick Bonner written on 3/27/2006 at 20:33
Original contribution: RE: RE: validation of purified water system written by A.v.Wijk on 3/22/2006 at 08:57) What you have to be able to show is that the PWS conforms to both EP and USP so you need to test to the tighest spec's. There are some differences in USP and EP which can be allowed for potable water, but purified needs to meet spec. If reduced testing is carried out it would have to done in such a way that you still had data to show the PWS was in spec. This can be achieved by using a matrix of tests at the point of use so all tests are covered, but not every time on every point. The bottom line though is you need enough data to satisfy and authority that the water being used meets the EP/USP test at all times.
I suggest you look at the FDA and EMEA web sites where there are a number of articles on PWS which should help.
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