The Info List - GxP

--- Advertisement ---

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 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]


1 Purpose 2 Examples of GxPs 3 See also 4 References

Purpose[edit] 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

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[edit]

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 cell culture practice, or GCCP[4] 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[5][6] 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[edit]

Best practice European Medicines Agency
European Medicines Agency
(EMA) Food and Drug Administration
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
Organisation for Economic Co-operation and Development
(OECD) Validation (drug manufacture) Society of Quality Assurance
Society of Quality Assurance
The Society of Quality Assurance
Society of Quality Assurance
(SQA) is a professional group focused on GxP-regulated environments.


^ ISPE - GAMP® Good Practice Guide: A Risk-Based Approach to GxP Compliant Laboratory Computerized Systems ^ United States Environmental Protection Agency
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.  ^ Coecke S. "Guidance on Good Cell Culture Practice".  ^ Food and Drug Administration
Food and Drug Administration
(2000). "Administrative Practices and Procedures; Good Guidance Practices". Archived from the original on 18 January 2009. Retrieved 10 April 2009.  ^ Food and Drug Administration. "Good Guidance Practices (GGP) Database". Archived from the original on 30 March 2009. Retrieved 10 April 2009. 

v t e

Social and environmental accountability

Ethics and principles

Aarhus Convention Corporate accountability / behaviour / social responsibility Ethical banking Ethical code Extended producer responsibility Organizational ethics Organizational justice Principles for Responsible Investment Social responsibility Stakeholder theory Sullivan principles Transparency (behavioral social) UN Global Compact

Social accounting

Double bottom line Ethical Positioning Index Higg Index Impact assessment (environmental equality social) ISO 26000 ISO 45001 Genuine progress indicator Performance indicator SA8000 Social return on investment Whole-life cost

Environmental accounting

Carbon accounting Eco-Management and Audit
Scheme Emission inventory Environmental full-cost accounting / impact assessment / management system / profit-and-loss account ISO 14000 ISO 14031:1999 Life-cycle assessment Pollutant release and transfer register Sustainability accounting / measurement / metrics and indices / standards and certification / supply chain Toxics Release Inventory Triple bottom line


Global Reporting Initiative GxP
guidelines Sustainability reporting


Community-based monitoring Environmental (certification) Fair trade (certification) ISO 19011


Bangladesh Accord Benefit corporation Child labour Community interest company Conflict of interest Disasters Disinvestment Eco-labeling Environmental pricing reform Environmental, social and corporate governance Ethical consumerism Euthenics Health impact assessment Market governance mechanism Product certification Public participation Social enterprise Socially responsible investing Stakeholder (engagement) Supply chain management

Environment portal Category Com