RE: Old equipment qualification Contribution from JD Mallet written on 7/14/2008 at 12:46
Original contribution: Old equipment qualification written by NAV on 7/14/2008 at 11:51) Nav,
To me, there is no regulatory requirement to use only "brand new" equipment but only equipment suitable for its use. Meaning that the equipment used should be qualified whatever it could be aged. Of course for an "old" equipment it is difficult to establish the full qualification picture but you can (and you have to) carry out and document the IQ, OQ and PQ steps. This for any equipment, old or new. Of course you may have to re-establish some technical drawings, but this is the GMP rule.
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