Can you please provide the procedure for reviewer qualification for batch Production Record and related general documents?
Is it required reviewer qualification for Batch Production Record and general documents? And please specify the reference guideline.
Hello!
The answer is yes, and guideline is FDA’s Guidance for Industry, Q7A Good Manufacturing Practice Guidance for Active Pharmaceutical Ingredients.
Since the Batch Production Record is a critical document to demonstrate product quality and compliance with cGMP, it must be reviewed by the Quality Unit (qualified personnel). I don’t know what you mean by “general documents”, but reviewers of non-critial steps must be qualified as well.
Here is an extract of FDA’s Guidance:
Batch production and laboratory control records of critical process steps should be reviewed and approved by the quality unit(s) before an API batch is released or distributed. Production and laboratory control records of noncritical process steps can be reviewed by qualified production personnel or other units following procedures approved by the quality unit(s).
There could be other guidances, but the rationale is the same.
I hope this helps.
Thank your very much sir
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