Hi Ambika
Quality Unit comprises of both QA + QC, so either of them can review
the records. I am refering to filled-in post mfg. If that's your query is......
Its not hard and fast rule that only QA does this as long as it is
under Quality unit responsibility.
As a genral system followed by most Indian Pharma Cos it is brought
under QA responsibility but its not necessary or mandatory that QA
only does it.
In my experience of auditing i have found this role + responsibility
coming under QC so they review production batch records also
(filled-in post mfg.) along with sample analysis and release of batch.
Originally coming from typical "indian" system of QA reviewing as
well as issuing batch records it was indeed a surprise for me
initially when i saw QC doing review and passing it on to QA and QP
(in EU concept) for final batch release as part of EU GMP.
So if you can convince your internal system why not get QC review it?
If i were to set-up a quality system all new in a new place i would do this!
I hope to have explained in a logical way which is what GMP also says
supposedly!
Madhu
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