In initial qualification of Injectable plant - we have to qualify first Area or Water?
Suggested that you should qualify first your manufacturing area (without HVAC & Water system installed) covering basic building aspects (All civil work)
In the subsequent phase, you can start qualifying Water system (IQ, OQ, OQ Phase-1, 2, 3)
And simultaneously initiate HVAC qualification.
This should be followed by other utilities qualification such as Pure steam, Compressed air, Nitrogen Vacuum, WFI generation system, etc.
Always there would be overlapping of these activities.
Then production & packing equipment & machines qualification (IQ, OQ) should be undertaken.
Then the entire facility should be released for routine production /process validation after conducting an internal GMP assessment / Audit by QA or by a qualified third party.
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So we cannot start HVAC qualifications without the utilities qualification such as Pure steam, Compressed air, Nitrogen Vacuum, WFI generation system?
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