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GxP
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
GxP
is frequently used to refer in a general way to a collection of quality guidelines.[1]

Contents

1 Purpose 2 Examples of GxPs 3 See also 4 References

Purpose[edit] The purpose of the GxP
GxP
quality guidelines is to ensure a product is safe and meets its intended use. GxP
GxP
guides quality manufacture in regulated industries including food, drugs, medical devices and cosmetics. The most central aspects of GxP
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
GxP
adherence. For more information, see good manufacturing practice. Examples of GxPs[edit]

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

See also[edit]

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

References[edit]

^ ISPE - GAMP® Good Practice Guide: A Risk-Based Approach to GxP Compliant Laboratory Computerized Systems ^ United States Environmental Protection Agency
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.  ^ K., Nitahara (Mar–Jun 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.  ^ Coecke S. "Guidance on Good Cell Culture Practice".  ^ Food and Drug Administration
Food and Drug Administration
(2000). "Administrative Practices and Procedures; Good Guidance Practices". Archived from the original on 18 January 2009. Retrieved 10 April 2009.  ^ Food and Drug Administration. "Good Guidance Practices (GGP) Database". Archived from the original on 30 March 2009. Retrieved 10 April 2009. 

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GxP
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