Friends:
This is a most basic of questions, and one that I know the answer to
- but what I am embarrassed about is that I do not know the exact
regulatory reference.
The Question: It is a principal of GMP (all GMPs worldwide) that
quality cannot directly report into production. Can anyone advise the
specific regulatory reference in the US cGMPs (21CR211 - what?) where
this is specifically stated? Any assist will be appreciated.
With Best Regards,
Michael Anisfeld
Globepharm Inc.
e-mail: manisfeld@globepharm.org
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