Thursday, January 13, 2011

Good Laboratory Practice

In the clinical and research arena, the phrase good laboratory practice or GLP generally refers to a system of management controls for laboratories and research organizations to ensure the consistency and reliability of results - as outlined in the Organisation for Economic Co-operation and Development (OECD) Principles of GLP and national regulations.
GLP was instituted following cases of safety and efficacy test fraud by pharmaceutical & industrial manufacturers; as a standard meant to ensure the quality, integrity, and reliability of safety data.

GLP applies to non-human (clinical) studies conducted for the assessment of the safety of chemicals to man, animals and the environment.
The internationally accepted definition reads:Good Laboratory Practice (GLP) embodies a set of principles that provides a framework within which laboratory studies are planned, performed, monitored, recorded, reported and archived. These studies are undertaken to generate data by which the hazards and risks to users, consumers and third parties, including the environment, can be assessed for pharmaceuticals (only preclinical studies), agrochemicals, cosmetics, food additives, feed additives and contaminants, novel foods, biocides, detergents etc.... GLP helps assure regulatory authorities that the data submitted are a true reflection of the results obtained during the study and can therefore be relied upon when making risk/safety assessments.
GLP can become confused with the standards of laboratory safety - wearing appropriate gloves, glasses and clothing to handle materials safely.

No comments:

Post a Comment