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Pharmaceutical Industry
Dr Priyank Tyagi
§ The bio/pharmaceutical industry
has created its own language and
GxP is one of many acronyms
that we all tend to use.
§ G = Good
x (variable replaced with
Manufacturing, Clinical,
Laboratory, Storage, Distribution
and Review)
P = Practice
§ As you can see, GxP is used as short-
hand form for referring to the
regulations established by the United
States Food and Drug Administration
which are published in the Code of
Federal Regulations.
GxP
§ Sometimes people refer to the
“GCPs” which specifically regards
the rules that govern clinical trials vs.
product manufacturing (GMPs) or
laboratory regulations (GLPs).
Purpose
regulated industries including food,
drugs, medical devices and cosmetics.