Good practice guidelines and regulations This article is about standards for quality assurance. For other uses, see GXP (disambiguation).
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Poster showing good hand-washing practice
A good practice is a procedure or set of procedures that are prescribed or accepted as being suitable or effective within a given professional or commercial setting. They are used in quality guidelines and regulations, including the pharmaceutical and food industries, for example good agricultural practice (GAP) (see more examples below).
In general, GxP is a placeholder abbreviation for the good practice within a particular field or fields, where the "x" can be substituted for the field(s) in question. GxP can also be used to refer to collections of quality guidelines.[1]
To denote the current good practice, a "c" or "C" is sometimes added to the front of the initialism (cGxP), which may hint that any good practice may be subject to future change. For example, "current good manufacturing practice" may be abbreviated "cGMP".
Purpose
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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 "ALCOA":[2]
Attributable: Documents are attributable to an individual
Legible: They are readable
Contemporaneously recorded: Not dated in the past (backdating) or the future (forward dating), but when the documented task is completed
Original or a true copy: See also non-repudiation
Accurate: Accurately reflecting the activity documented
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
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Good agricultural and collection practices, or GACP(s)
Good agricultural practice, or GAP
Good auditing practice, or GAP
Good automated laboratory practice, or GALP[3][4]
Good automated manufacturing practice, or GAMP
Good business practice, or GBP
Good cell culture practice, or GCCP[5]
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[6][7]
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
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Best practice, a method or technique that has been generally accepted as superior to alternatives because it tends to produce superior results
European Medicines Agency (EMA), European Union agency evaluating and supervising pharmaceutical products
Food and Drug Administration (FDA), a United States Food federal agency protecting and promoting public health through the control and supervision
International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH), initiative to bring together regulatory authorities and pharmaceutical industry
Organisation for Economic Co-operation and Development (OECD), intergovernmental organisation for stimulating economic progress and world trade through democracy, market economy, and good practices
Pride of workmanship, sense of having done good work, an element of job satisfaction
Validation (drug manufacture), a documented process to ensure a product meets its required specifications and quality
References
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^ISPE - GAMP® Good Practice Guide: A Risk-Based Approach to GxP Compliant Laboratory Computerized Systems
^ALCOA to ALCOA Plus and Data integrity » Pharmaguddu
^United States Environmental Protection Agency. "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. Archived from the original on 25 August 2021. Retrieved 25 February 2012.
^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.
^Coecke S. "Guidance on Good Cell Culture Practice".
^Food and Drug Administration (2000). "Administrative Practices and Procedures; Good Guidance Practices". Food and Drug Administration. Archived from the original on 18 January 2009. Retrieved 10 April 2009.
^Food and Drug Administration. "Good Guidance Practices (GGP) Database". Food and Drug Administration. Archived from the original on 30 March 2009. Retrieved 10 April 2009.
