Learnaboutgmp Community

Raising of Deviations


I am of the opinion that a deviation should be raised during an IQ/ OQ where there is a breach of an acceptance criteria laid down / specified. However, our course of action is to fix and retest.
Can anyone comment as to why this is poor practice?

Also safety of product and personnel are important and should be assessed as part of the IQ. Should this be addressed in the IQ?

Thank you for your time.


Dear Austin,

I have already given the answer. Kindly see

Thanks and best regards,