GxP is a general abbreviation for the "good practice"

quality Quality may refer to: Concepts *Quality (business), the ''non-inferiority'' or ''superiority'' of something *Quality (philosophy), an attribute or a property *Quality (physics), in response theory * Energy quality, used in various science discipl ...

guidelines and regulations. The "x" stands for the various fields, including the

pharmaceutical A medication (also called medicament, medicine, pharmaceutical drug, medicinal drug or simply drug) is a drug used to diagnose, cure, treat, or prevent disease. Drug therapy ( pharmacotherapy) is an important part of the medical field and ...

and food industries, for example

good agricultural practice Good agricultural practice (GAP) is a certification system for agriculture, specifying procedures (and attendant documentation) that must be implemented to create food for consumers or further processing that is safe and wholesome, using sustaina ...

, 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 acronym for "current good manufacturing practice". The term GxP is frequently used to refer in a general way to a collection of quality guidelines.

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 Current good manufacturing practices (cGMP) are those conforming to the guidelines recommended by relevant agencies. Those agencies control the authorization and licensing of the manufacture and sale of food and beverages, cosmetics, pharmaceut ...

Examples of GxPs

* Good agricultural and collection practices, or GACP(s) *

Good agricultural practice Good agricultural practice (GAP) is a certification system for agriculture, specifying procedures (and attendant documentation) that must be implemented to create food for consumers or further processing that is safe and wholesome, using sustaina ...

, 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 Good clinical data management practice (GCDMP) is the current industry standards for clinical data management that consist of best business practice and acceptable regulatory standards. In all phases of clinical trials, clinical and laboratory inf ...

, or GCDMP *

Good clinical laboratory practice Good clinical laboratory practice (GCLP) is a GxP guideline for laboratory samples from clinical studies. Good clinical practice (GCP) does not define requirements for laboratories and good laboratory practice (GLP) focusses on pre-clinical analys ...

, or GCLP *

Good clinical practice Good clinical practice (GCP) is an international quality standard, which governments can then transpose into regulations for clinical trials involving human subjects. GCP follows the International Council for Harmonisation of Technical Requirements ...

, or GCP * Good documentation practice, or GDP, or GDocP (to distinguish from "good distribution practice") * Good

distribution Distribution may refer to: Mathematics * Distribution (mathematics), generalized functions used to formulate solutions of partial differential equations *Probability distribution, the probability of a particular value or value range of a vari ...

practice, or GDP *

Good engineering practice "Good engineering practice" or "GEP" is engineering and technical activities that ensure that a company manufactures products of the required quality as expected (e.g., by the relevant regulatory authorities). Good engineering practices are to ensur ...

, or GEP * Good financial practice, or GFP *

Good guidance practice Administrative guidance is non-binding advice given by an administrative agency to the public regarding how best to comply with a particular law or regulation. It may also be referred to by terms such as "advice" or "recommendation." Guidance is ...

, or GGP *

Good horticultural practice In most contexts, the concept of good denotes the conduct that should be preferred when posed with a choice between possible actions. Good is generally considered to be the opposite of evil and is of interest in the study of ethics, morality, ph ...

, or GHP *

Good hygiene practice In most contexts, the concept of good denotes the conduct that should be preferred when posed with a choice between possible actions. Good is generally considered to be the opposite of evil and is of interest in the study of ethics, morality, ph ...

, or GHP * Good laboratory practice, or GLP *

Good management practice In most contexts, the concept of good denotes the conduct that should be preferred when posed with a choice between possible actions. Good is generally considered to be the opposite of evil and is of interest in the study of ethics, morality, ph ...

, or GMP *

Good manufacturing practice Current good manufacturing practices (cGMP) are those conforming to the guidelines recommended by relevant agencies. Those agencies control the authorization and licensing of the manufacture and sale of food and beverages, cosmetics, pharmaceut ...

, or GMP *

Good microbiological practice In most contexts, the concept of good denotes the conduct that should be preferred when posed with a choice between possible actions. Good is generally considered to be the opposite of evil and is of interest in the study of ethics, morality, ph ...

, or GMiP *

Good participatory practice In most contexts, the concept of good denotes the conduct that should be preferred when posed with a choice between possible actions. Good is generally considered to be the opposite of evil and is of interest in the study of ethics, morality, ph ...

, or GPP *

Good pharmacovigilance practice In most contexts, the concept of good denotes the conduct that should be preferred when posed with a choice between possible actions. Good is generally considered to be the opposite of evil and is of interest in the study of ethics, morality, ph ...

, or GPvP or even GVP *

Good pharmacy practice In most contexts, the concept of good denotes the conduct that should be preferred when posed with a choice between possible actions. Good is generally considered to be the opposite of evil and is of interest in the study of ethics, morality, ph ...

, or GPP *

Good policing practice In most contexts, the concept of good denotes the conduct that should be preferred when posed with a choice between possible actions. Good is generally considered to be the opposite of evil and is of interest in the study of ethics, morality, ph ...

, 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

References

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Good In most contexts, the concept of good denotes the conduct that should be preferred when posed with a choice between possible actions. Good is generally considered to be the opposite of evil and is of interest in the study of ethics, morality, ph ...

Purpose

Examples of GxPs

See also

References