ICH Q7 Good Manufacturing
Practice Guidance
for Active Pharmaceutical Ingredients
The ICH Q7 guidance
document is intended
to provide guidance
regarding good
manufacturing practice
(GMP) for the manufacturing
of active pharmaceutical
ingredients (APIs) under an
appropriate system for
managing quality. It is
also intended to help
ensure that APIs meet
the quality and purity
characteristics that they
purport, or are represented,
to possess.
Active Pharmaceutical
Ingredients (API)
Active Pharmaceutical
Ingredients (API) are
active chemicals used
in the manufacturing
of drugs. Another term
for Active Pharmaceutical
Ingredient is "Bulk Drug
Substance" although API
is more internationally
recognized.
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