RE: Role QA in qualification
Contribution from Dick Bonner written on 5/21/2003 at 12:29
Original contribution: Role QA in qualification written by Sven Van de Ven on 4/29/2003 at 15:54)
There are many documents on this topic but the agency expectations are that all validation protocols and data packages are approved by the Quality Unit.Equipment qualification( if GMP Equipment) should also be approved by the Quality Unit. The protocols should include the DQ/IQ/OQ/PQ and within these should be clear acceptance criteria , signed off by the Quality Unit, which equipment must pass to be successfully qualified.
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