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GxP

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GxP is a general abbreviation for the "good

practice" quality guidelines and
regulations. The "x" stands for the various
fields, including the pharmaceutical and
food industries, for example good
agricultural practice, or GAP.
A "c" or "C" is sometimes added to the
front of the initialism. The preceding "c"
stands for "current." For example, cGMP is
an acronym for "current good
manufacturing practice". The term GxP is
frequently used to refer in a general way to
a collection of quality guidelines.[1]

Purpose
The purpose of the GxP quality guidelines
is to ensure a product is safe and meets
its intended use. GxP guides quality
manufacture in regulated industries
including food, drugs, medical devices and
cosmetics.

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.

Documentation is a critical tool for

ensuring GxP adherence. For more
information, see good manufacturing
practice.

Examples of GxPs
Good agricultural and collection
practices, or GACP(s)
Good agricultural practice, or GAP
Good auditing practice, or GAP
Good automated laboratory practice, or
GALP[2][3]
Good automated manufacturing
practice, or GAMP
Good business practice, or GBP
Good cell culture practice, or GCCP[4]
Good clinical data management
practice, or GCDMP
Good clinical laboratory practice, or
GCLP
Good clinical practice, or GCP
Good documentation practice, or GDP, or
GDocP (to distinguish from "good
distribution practice")
Good distribution practice, or GDP
Good engineering practice, or GEP
Good financial practice, or GFP
Good guidance practice, or GGP[5][6]
Good horticultural practice, or GHP
Good hygiene practice, or GHP
Good laboratory practice, or GLP
Good management practice, or GMP
Good manufacturing practice, or GMP
Good microbiological practice, or GMiP
Good participatory practice, or GPP
Good pharmacovigilance practice, or
GPvP or even GVP
Good pharmacy practice, or GPP
Good policing practice, or GPP
Good recruitment practice, or GRP
 Good research practice, or GRP
Good safety practice, or GSP
Good storage practice, or GSP
Good tissue practice, or GTP

See also
Best practice
European Medicines Agency (EMA)
Food and Drug Administration (FDA)
International Conference on
Harmonisation of Technical
Requirements for Registration of
Pharmaceuticals for Human Use (ICH)
 Organisation for Economic Co-operation
and Development (OECD)
Validation (drug manufacture)
Society of Quality Assurance The
Society of Quality Assurance (SQA) is a
professional group focused on GxP-
regulated environments.

References
1. ISPE - GAMP® Good Practice Guide: A
Risk-Based Approach to GxP
Compliant Laboratory Computerized
Systems
2. United States Environmental
Protection Agency (1995). "Good
Automated Laboratory Practices -
Principles and Guidance to
Regulations for Ensuring Data Integrity
in Automated Laboratory Operations" .
U.S. EPA, Office of Information
Resources Management. Retrieved
25 February 2012.
3. K., Nitahara (March–June 1993).
"Good Automated Laboratory
Practices and other standards:
validation of computer systems in the
 PC environment". Qual Assur. 2 (1–2):
96–101. PMID 8156229 .
4. Coecke S. "Guidance on Good Cell
Culture Practice" .
5. Food and Drug Administration (2000).
"Administrative Practices and
Procedures; Good Guidance
Practices" . Archived from the original
on 18 January 2009. Retrieved
10 April 2009.
6. Food and Drug Administration. "Good
Guidance Practices (GGP) Database" .
Archived from the original on 30
March 2009. Retrieved 10 April 2009.
Retrieved from
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Last edited 9 days ago by Bender the Bot

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