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Contacting GQA
Global
Quality Alliance, LLC
P.O. Box 531
Manassa,
Colorado 81141
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Global
Quality Alliance
Quality
Assurance Consulting for the
Pharmaceutical, Biotechnology, Dietary Supplement, and
Medical Device Industries
Global
Quality Alliance, LLC - revision 1/2010
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ICH
Q10:
ICH
Q10 describes
one comprehensive
approach to an effective
pharmaceutical quality
system that is based on
ISO concepts, includes
applicable Good
Manufacturing Practice
(GMP) regulations
and complements ICH Q8
"Pharmaceutical Development"
and ICH Q9 "Quality Risk
Management". ICH Q10 is
a model for a
pharmaceutical quality
system that can be
implemented throughout
the different stages
of a product lifecycle.
Much of the content
of ICH Q10 applicable
to manufacturing sites
is currently specified
by regional GMP
requirements. ICH Q10
is not intended to
create any new expectations
beyond current regulatory
requirements. Consequently,
the content of ICH Q10
that is additional to
current GMP requirements
is optional.
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