Michael,
Nice question! I also could not find the answer in 21CFR211. But in
case of API GMP (Q7A, applicable to US also), that is specified as
follow-
"2.13 There should be a quality unit(s) that is independent of
production and that fulfills both quality assurance (QA) and quality
control (QC) responsibilities. This can be in the form of separate QA
and QC units or a single individual or group, depending upon the size
and structure of the organization."
In case of formulation, I am also waiting to hear from the group.
Regards,
Tilak Sha
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