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PQ

Contribution from Sven Pommeranz written on 3/20/2002 at 08:38

The PIC/S Document PI 006-1 (formerly PR 1/99) states that the PQ is equivalent to Process Validation. Annex 15 differs between PQ and Process Validation. Do we have to fulfil Annex 15 requirements or not? What´s about the FDA?

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