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In the experimental (non-clinical) research arena, good laboratory practice or GLP is a quality management system for research laboratories and organizations to ensure the uniformity, consistency, reliability, reproducibility, quality and integrity of products for human or development purposes. Animal health (including pharmaceuticals) through non-clinical safety testing; From physio-chemical properties through acute to chronic toxicity tests.
GLP was first introduced in 1972 in New Zealand and Denmark and later in 1978 in the United States in response to the Industrial Biotest Labs scandal. It followed the Organization for Economic Co-operation and Development (OECD) GLP guidelines a few years later in 1992; The OECD has since helped promote GLP in many countries.
GLP applies to non-clinical studies conducted to assess the safety or efficacy of products in development (including pharmaceuticals) for humans, animals and the environment. GLP, a data and operational quality system, is not the same as laboratory safety standards—appropriate gloves, goggles, and clothing for safe handling of lab materials. The principles of GLP are to ensure and promote the safety, consistency, high quality and reliability of chemicals in non-clinical and laboratory testing processes. GLP is not limited to chemical products and also applies to medical devices, food additives, food packaging, color additives, animal feed additives, other non-pharmaceutical products or ingredients, biological products and electronic products.
GLP was first introduced in 1972 in New Zealand and Denmark. GLP was established in the United States after incidents of fraud generated by toxicology labs in data submitted to the FDA by pharmaceutical companies. The most notable case was Industrial Biotest Labs (IBT), where thousands of safety tests for chemical manufacturers were claimed to have been falsely performed or were so bad that police investigators couldn’t piece together what had been done…although IBT overtook the aforementioned manufacturers. provided their contract test results.
These issues were made public in US Congressional hearings, leading to FDA’s publication of the proposed regulation on GLP in 1976, with the establishment of the final rule in June 1979 (21 CFR 58). The Environmental Protection Agency (EPA) faced similar problems with the data submitted to it and issued its own draft GLP regulations in 1979 and 1980, publishing the final regulations in two separate parts (40 CFR 160 and 40 CFR 792) in 1983.
