Английская Википедия: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 abbreviation 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 Good Documentation Practices (GDP), which are expected to be 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[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 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
