GxP

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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 end 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 Practices". 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:

  • 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.

List of GxPs

See also

References

  1. ISPE - GAMP® Good Practice Guide: A Risk-Based Approach to GxP Compliant Laboratory Computerized Systems
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