GxP
GxP is a general term for good (anything...) practice quality guidelines and regulations. These guidelines are used in many fields, including the pharmaceutical and food industries.
The titles of these good practice guidelines usually begin with "good" and ends 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.
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 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 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[4][5]
- 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
- 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)
- Japan Ministry of Health
- 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
- ↑ ISPE - GAMP® Good Practice Guide: A Risk-Based Approach to GxP Compliant Laboratory Computerized Systems
- ↑ 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.
- ↑ Food and Drug Administration (2000). "Administrative Practices and Procedures; Good Guidance Practices". Retrieved 10 April 2009. Archived 18 January 2009 at the Wayback Machine.
- ↑ Food and Drug Administration. "Good Guidance Practices (GGP) Database". Retrieved 10 April 2009. Archived 30 March 2009 at the Wayback Machine.
