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The Application of the GLP Principles to Field Studies - PharmaFacts
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The Application of the GLP Principles to Field Studies

Guidances - OECD Guidances

The Principles of Good Laboratory Practice (GLP), as adopted by the OECD in 1981 and revised in 1997, provide recommended test management standards for a wide variety of studies done for regulatory purposes or other assessment-related purposes. The report of the Expert Group1 which developed the GLP Principles in 1981 expressly lists the following types of tests as covered by the GLP Principles:
· physico-chemical properties;
· toxicological studies designed to evaluate human health effects (short- and long-term);
· ecotoxicological studies designed to evaluate environmental effects (short- and long-term);
and
· ecological studies designed to evaluate environmental chemical fate (transport, biodegradation, and bioaccumulation).

Testing intended to determine the identity and magnitude of pesticide residues, metabolites, and related compounds for tolerance and other dietary exposure purposes is also included in the overall classification of ecological studies.  The GLP Principles are intended to cover a broad range of
commercial chemical products including pesticides,  pharmaceuticals, cosmetics, veterinary drugs as well as food additives, feed additives and industrial chemicals.

The_Application_of_the_GLP_Principles_to_Field_Studies.pdf