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Pharmaceuticals/SOME PQ BEFOR OQ TESTS


good morning sir hoping you are fine i send  to you sir because i face big problem in this case i am working now in a big company for pharmaceutical industry in the field of Qualification and i faced a problem belongs to HVAC system as the manufacturer of AHUS IN HIS SCOPE DOING some PQ tests such as (recovery,leakage test of filter,air velocity ,air change )but he done these tests before OQ tests are completed as we do the PQ  tests i mentioned to you in 9/2012 and we do the calibration of the AHUS SENSORS and gauges in12/2012 its accepted to an audit or not and if its accepted through deviation pls give me the correct justification with reference and if not accepted tell me pl what can ido to face an audit with this problem thanks

You should not have performed the PQ testing before the OQ testing was completed and the approved report issued.

However all you can do now is either write a deviation notice explaining what happened, and justifying why it does not negate any of the PQ tests performed; or you can repeat the PQ - which for some elements you need to do annually anyway.


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Michael Anisfeld


Disclaimer: SORRY BUT I DO NOT ANSWER QUESTIONS RELATED TO: DRUG ACTIONS/INTERACTIONS, INTERNET DRUG PURCHASES, RESULTS OF DRUG TESTS, IDENTIFYING DRUGS (FOR WHICH YOUR LOCAL PHARMACIST IS THE BEST PERSON TO CONSULT). My expertise is answering questions relating to pharmaceutical manufacturing and quality technologies, drug regulations and specifically GMP requirements


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