what is glp

what is glp

1 year ago 68
Nature

Good Laboratory Practice (GLP) is a quality system of management controls for research laboratories and organizations to ensure the uniformity, consistency, reliability, and quality of non-clinical studies conducted for the assessment of the safety or efficacy of products in development, including pharmaceuticals, for people, animals, and the environment. GLP was first introduced in New Zealand and Denmark in 1972, and later in the US in 1978 in response to the Industrial BioTest Labs scandal. The OECD Principles of GLP were introduced in 1992 and have since helped promulgate GLP to many countries. GLP is not the same as standards for laboratory safety, which include appropriate gloves, glasses, and clothing to handle lab materials safely. GLP applies to many other non-pharmaceutical agents such as color additives, food additives, food contamination limits, food packaging, and medical devices. GLP is a quality management system, not a scientific management system, and defines a set of quality standards for study conduct, data collection, and results reporting. GLP only applies to non-clinical studies and testing and does not apply to clinical studies, which are governed by Good Clinical Practices (GCP) and other regulations intended to protect human participant safety. GLP regulations in the US, UK, and EU have similar GLP requirements since they are members of the OECD.

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