Good 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 .
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 in question. GxP can also be used to refer to collections of quality guidelines.
To denote the current good practice, a "c" or "C" is sometimes added to the front of the initialism, which may hint that any good practice may be subject to future change. For example, "current good manufacturing practice" may be abbreviated "cGMP".
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, which are expected to be "ALCOA":Attributable: Documents are attributable to an individualLegible: They are readableContemporaneously recorded: Not dated in the past or the future, but when the documented task is completedOriginal or a true copy: See also non-repudiationAccurate: Accurately reflecting the activity documentedPermanent
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.
Examples of GxPs
- Good agricultural and collection practices, or GACP
- Good agricultural practice, or GAP
- Good auditing practice, or GAP
- Good automated laboratory practice, or GALP
- Good automated manufacturing practice, or GAMP
- Good business practice, or GBP
- Good cell culture practice, or GCCP
- 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
- Good distribution practice, or GDP
- Good engineering practice, or GEP
- Good financial practice, or GFP
- Good guidance practice, or GGP
- 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