Good Manufacturing Practice is a set of regulations, codes, and guidelines for the manufacture of drugs (known as medicinal products in Europe), medical devices, diagnostic products, foods products and Active Pharmaceutical Ingredients (APIs). The term "current" Good Manufacturing Practices or "cGMPs" refers the way the pharmaceutical product regulations are called in U.S. in order to emphasize that the expectations are dynamic.

Since sampling products will statistically only ensure that the samples themselves (and perhaps the areas adjacent to where the samples were taken) are suitable for use, and end-point testing relies on sampling, GMP takes the holistic approach of regulating the production and laboratory testing environment itself. An extremely important part of GMPs is documenting every aspect of the process, activities, and of operations. If the documentation is not correct and in order, showing how the product was made and tested, that allows for traceability, and recall from the market in the event of future problems, then the product is considered contaminated (in the US considered adulterated).

The World Health Organization (WHO) version

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The World Health Organization (WHO) version of GMPs is used by pharmaceutical regulators and the pharmaceutical industry in over 100 countries worldwide, primarily in the developing world. In the European Union, the EU-GMPs, with more compliance requirements than those stated in the WHO GMPs are in force; while in the USA, FDA's version of GMPs, including requirements over and above those stated in the WHO document, are enforced. Similar forms of GMP are used in other countries, with Australia, Canada, Japan, Singapore and others having highy developed/sophisticated GMP requirements.

Since the publication in 1999 by the International Conference on Harmonization (ICH) of "GMPs for Active Pharmaceutical Ingredients", GMPs also apply in those countries and trade groupings that are signatories to ICH (the EU, Japan and the USA) and other countries who adopt ICH Guidelines (e.g. Australia, Canada, Singapore) to the manufacture and testing of active raw materials.

Other Good Practices

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Other 'Good Practice' systems, along the same lines as GMP, exist. "Good Laboratory Practice" (GLP) for laboratories conducting non-clinical studies (toxicology and pharmacology studies in animals); "Good Clinical Practices" (GCP) for hospitals and clinicians conducting clinical studies on new drugs in humans; "Good Distribution Practices" (GDP) for wholesalers and distributors.

Collectively these 'Good Practice' requirements, and others not mentioned here, are referred to as 'GxP' requirements, and all follow similar philosophies.

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