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GxP and cGxP in Bio/

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.

§ While this may seem


“elementary” to some of you,

GxP many people may not know what


this means.

§ 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).

§ Together, these are known


collectively as the “predicate rules”
that govern a wide spectrum of
regulatory obligations across this
diverse industry.
§ “GxP” is a collective term for the
Good Practice quality guidelines
and regulations used in many
fields, encompassing such
internationally-recognized
standards as GMP, GCP, GLP, GSP,
GDP and GRP.

GxP § GxP guidelines are designed to


ensure that products are safe,
meet their intended use and, in
regulated industries such as
drugs, food, medical devices and
cosmetics, adhere to quality
processes during manufacturing,
control, storage and distribution.
§ GxP is a general term for Good
Practice quality guidelines and
regulations. These guidelines are
used in many fields, including the
pharmaceutical and food industries.

§ The titles of these good practice

GxP guidelines usually begin with "Good"


and end in "Practice", with the
specific practice descriptor in
between.

§ GxP represents the abbreviations of


these titles, where x (a common
symbol for a variable) represents the
specific descriptor.
GxP
1. GMP – (Good manufacturing
Practice)
2. GCP – (Good Clinical Practice)
3. GLP – (Good Laboratory
List of GxP’s in Practice)
Pharmaceuticals 4. GSP – (Good Storage Practice)
5. GDP – (Good Distribution
practice)
6. GRP – (Good Review Practice)
§ The purpose of the GxP quality
guidelines is to ensure a product is safe
and meets its intended use.

§ GxP guides quality manufacture in

Purpose
regulated industries including food,
drugs, medical devices and cosmetics.

of GxP § The most central aspects of GxP are:


§ Traceability: the ability to reconstruct the
development history of a drug or medical
device.
§ Accountability: the ability to resolve who
has contributed what to the development
and when.