GxP

This article is about standards for quality assurance. For other uses, see GXP (disambiguation).

GxP is a general term for good (anything...) practice quality guidelines and regulations. These guidelines are used in many fields, including the pharmaceutical and food industries.

The titles of these good practice guidelines usually begin with "good" and ends in "practice", with the specific practice descriptor in between. GxP represents the abbreviations of these titles, where x (a common symbol for a variable) represents the specific descriptor.

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]

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:

Documentation is a critical tool for ensuring GxP adherence. For more information, see good manufacturing practice.

Examples of GxPs

See also

References

  1. ISPE - GAMP® Good Practice Guide: A Risk-Based Approach to GxP Compliant Laboratory Computerized Systems
  2. 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.
  3. 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.
  4. Food and Drug Administration (2000). "Administrative Practices and Procedures; Good Guidance Practices". Retrieved 10 April 2009. Archived 18 January 2009 at the Wayback Machine.
  5. Food and Drug Administration. "Good Guidance Practices (GGP) Database". Retrieved 10 April 2009. Archived 30 March 2009 at the Wayback Machine.
This article is issued from Wikipedia - version of the Wednesday, May 04, 2016. The text is available under the Creative Commons Attribution/Share Alike but additional terms may apply for the media files.