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What is GxP compliance?

By Zippia Team - Feb. 1, 2023

GxP compliance refers to an organization adhering to a set of quality guidelines and regulations that are in place with the objective of the safety of products considered to be of the life science variety and to also ensure the accuracy of the data that is used to determine product-related safety. It also encompasses the process quality in these stages:

  • Manufacturing

  • Control

  • Storage

  • Distribution

The specific term of GxP actually includes a wide variety of compliance-related activities, some common examples are:

  • Good Manufacturing Practices (GMP)

  • Good Laboratory Practices (GLP)

  • Good Clinical Practices (GCP)

Organizations participating in the creation or selling of life science-related products must meet specific requirements based on the type of product, and the country in which the product is going to be sold.

The main goal of GxP compliance is to ensure the safety of consumers that purchase food and medical products. GxP standards were first set forth by the Food and Drug Administration (FDA). Here is a simple breakdown of what GxP stands for:

  • G - stands for Good

  • x - stands for the Variable

  • P - stands for Practices

What is GxP compliance?
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