Question In my experience with validation protocols, the IQ/OQ is written and performed separately from the PQ. Is there any reason why the PQ could not or should not be included within the IQ/OQ?
The IQ/OQ are essentially engineering studies to confirm that the equipment works correctly.
The PQ is the culmination of process development to show that the process works correctly. You would not want to waste time (and potentially valuable ingredients) on the PQ if the IQ/OQ had failed.
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