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Good Laboratory Practices

By definition Good Laboratory Practices (GLP) are quality control systems used to assess the safety of chemicals to man and the environment. It monitors the manner in which non-clinical studies are: planned, performed, recorded, reported, and archived.

On December 22, 1978 the FDA published the GLP regulations. They came into effect June 1979, The Federal Food, Drug, And Cosmetic Act and the Public Health Service Act require that sponsors of FDA-regulated products submit evidence of their product’s safety in research and/or marketing applications.

These include food and color additives, drugs, biological and diagnostic products, and medical and electronic devices. The FDA uses this data to answer questions regarding:

The toxicity profile of the test article.
The observed no adverse effect.
The dose level in the test system. The risks associated with clinical studies involving humans or animals.
The potential teratogenic, carcinogenic, or other adverse effects of the test article.
The level of use that can be approved.

Here is a partial FDA GLP slide show. (slides 12-15 only) For a complete overview of the these practices please visit the FDA's Division of Scientific Investigations.

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