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 discipli ...
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 re ...
and
food industries
The food industry is a complex, global network of diverse businesses that supplies most of the food consumed by the world's population. The food industry today has become highly diversified, with manufacturing ranging from small, traditiona ...
, 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, pharmaceutica ...
.
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
Good automated manufacturing practice (GAMP) is both a technical subcommittee of the International Society for Pharmaceutical Engineering (ISPE) and a set of guidelines for manufacturers and users of automated systems in the pharmaceutical industry ...
, 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 in ...
, 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
Good documentation practice (commonly abbreviated GDP, recommended to abbreviate as GDocP to distinguish from "good distribution practice" also abbreviated GDP) is a term in the pharmaceutical and medical device industries to describe standards by ...
, 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, 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
In the experimental (non-clinical) research arena, good laboratory practice or GLP is a quality system of management controls for research laboratories and organizations to ensure the uniformity, consistency, reliability, reproducibility, quality, ...
, or GLP
*
Good management practice, 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, pharmaceutica ...
, 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
A best practice is a method or technique that has been generally accepted as superior to other known alternatives because it often produces results that are superior to those achieved by other means or because it has become a standard way of doing ...
*
European Medicines Agency
The European Medicines Agency (EMA) is an agency of the European Union (EU) in charge of the evaluation and supervision of medicinal products. Prior to 2004, it was known as the European Agency for the Evaluation of Medicinal Products or Euro ...
(EMA)
*
Food and Drug Administration
The United States Food and Drug Administration (FDA or US FDA) is a List of United States federal agencies, federal agency of the United States Department of Health and Human Services, Department of Health and Human Services. The FDA is respon ...
(FDA)
*
(ICH)
*
Organisation for Economic Co-operation and Development
The Organisation for Economic Co-operation and Development (OECD; french: Organisation de coopération et de développement économiques, ''OCDE'') is an intergovernmental organization, intergovernmental organisation with 38 member countries ...
(OECD)
*
Validation (drug manufacture)
Validation is the process of establishing documentary evidence demonstrating that a procedure, process, or activity carried out in testing and then production maintains the desired level of compliance at all stages. In the pharmaceutical industry, ...
*
Society of Quality Assurance, a professional group focused on GxP-regulated environments
References
{{Social accountability
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 ...