Editing GxP

{{Short description|Good practice guidelines and regulations}}
{{About|standards for quality assurance||GXP (disambiguation)}}
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{{More footnotes needed|date=November 2010}}
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'''GxP''' is a general abbreviation for the "good practice" [[Quality (business)|quality]] guidelines and regulations. The  "x" stands for the various fields, including the [[pharma industry|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 abbreviation for "current good manufacturing practice".  The term GxP is frequently used to refer in a general way to a collection of quality guidelines.<ref>[http://www.ispe.org/gamp-good-practice-guide/gxp-compliant-laboratory-computerized-systems ISPE - GAMP® Good Practice Guide: A Risk-Based Approach to GxP Compliant Laboratory Computerized Systems]</ref>

== 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 Good Documentation Practices (GDP), which are expected to be '''[https://pharmaguddu.com/alcoa-to-alcoa-plus-data-integrity/ ALCOA]''':
* Attributable: documents are attributable to an individual
* Legible:       they are readable
* Contemporaneously Recorded: not dated in the past or the future, but when the documented task is completed
* Original or a True Copy
* Accurate: accurately reflecting the activity documented
* and Permanent,

The products that are the subject of the GxP are expected to be
* 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.

GxPs require that a Quality System be established, implemented, documented, and maintained.

As explained above, 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<ref>{{cite web |last=United States Environmental Protection Agency |author-link=United States Environmental Protection Agency |title=Good Automated Laboratory Practices - Principles and Guidance to Regulations for Ensuring Data Integrity in Automated Laboratory Operations |url=http://cfpub.epa.gov/ols/catalog/catalog_display.cfm?&FIELD1=SUBJECT&INPUT1=Automation&TYPE1=EXACT&item_count=45 |publisher=U.S. EPA, Office of Information Resources Management |access-date=25 February 2012}}</ref><ref>{{cite journal |author=K., Nitahara |title=Good Automated Laboratory Practices and other standards: validation of computer systems in the PC environment |date=Mar–Jun 1993 |volume=2 |issue=1–2 |pages=96–101 |journal=Qual Assur |pmid=8156229}}</ref>
* [[Good automated manufacturing practice]], or GAMP
* [[Good business practice]], or GBP
* [[Good cell culture practice]], or GCCP<ref>{{cite web|last= Coecke S.|title=Guidance on Good Cell Culture Practice| url=https://www.researchgate.net/publication/7583114}}</ref>
* [[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 [[drug distribution|distribution]] practice, or GDP
* [[Good engineering practice]], or GEP
* [[Good financial practice]], or GFP
* [[Guidance document#Good guidance practice|Good guidance practice]], or GGP<ref name=appg>{{cite web| last =Food and Drug Administration| author-link =Food and Drug Administration| title =Administrative Practices and Procedures; Good Guidance Practices| website =[[Food and Drug Administration]]| year =2000| url =https://www.fda.gov/cder/audiences/iact/GGP.htm| access-date =10 April 2009| url-status =dead| archive-url =https://web.archive.org/web/20090118041436/https://www.fda.gov/cder/audiences/iact/GGP.htm| archive-date =18 January 2009| df =dmy-all}}</ref><ref name=ggpd>{{cite web| last =Food and Drug Administration| author-link =Food and Drug Administration| title =Good Guidance Practices (GGP) Database| website =[[Food and Drug Administration]]| url =https://www.fda.gov/cdrh/ggpmain.html| access-date =10 April 2009| url-status =dead| archive-url =https://web.archive.org/web/20090330133004/https://www.fda.gov/cdrh/ggpmain.html| archive-date =30 March 2009| df =dmy-all}}</ref>
* [[Good hygiene practice]], or GHP
* [[Good hygiene practice]], or GHP
* [[Good laboratory practice]], or GLP
* [[Good machine learning practice]], or GMLP
* [[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)]]

== References ==
{{Reflist}}

{{Social accountability}}

[[Category:Quality|Good]]
[[Category:Good practice| ]]