Good Laboratory Practice (GLP)
Good Laboratory Practice
---- GLP is the abbreviation of Good Laboratory Practice in English, Chinese Literally translated as good laboratory practice or standard laboratory practice. GLP is a regulatory document formulated for the management of laboratory experimental research from planning, experimentation, supervision, recording to experimental reporting, etc., involving all aspects of laboratory work that can affect the results and interpretation of experimental results. It is mainly a specification developed for safety evaluation experiments of medicines, pesticides, food additives, cosmetics, veterinary drugs, etc. The main purpose of formulating GLP is to strictly control all aspects of chemical safety evaluation tests, that is, to strictly control various subjective and objective factors that may affect the accuracy of experimental results, reduce experimental errors, and ensure the authenticity of experimental results.
GLP began in the 1970s. New Zealand was the first country to establish a laboratory registration law. In 1976, the U.S. Food and Drug Administration (FDA) formulated draft GLP specifications that were limited to pharmaceuticals. In 1980, the U.S. Environmental Protection Agency (EPA) issued GLP standards for pesticides in the Federal Insecticide, Fungicide, and Rodenticide Act. Canada, Japan, South Korea and other countries have successively issued their own GLP regulations. The European Organization published draft regulations on drug pharmacology and toxicology, clinical and clinical standards in May 1975, proposed a GLP draft in 1986, and issued a GLP inspection decree in 1988. European Community GLP is consistent with the GLP principles of the Organization for Economic Co-operation and Development (OECD).
my country first started GLP certification activities in the pharmaceutical industry. In December 1993, the former State Food and Drug Administration promulgated the "Regulations on the Quality Management of Non-clinical Drug Research" (for trial implementation). The State Environmental Protection Administration and other ministries and commissions have also successively formulated GLP standards for this industry. GLP work in my country's pesticide industry began in 2002. From 2002 to 2003, the Pesticide Control Institute of the Ministry of Agriculture and the Shenyang Chemical Industry Research Institute jointly undertook the sub-project of the "Tenth Five-Year Plan" national major scientific and technological research project "New Pesticide Creation Research and Industrialization Key Technology Development" - "Pesticide Safety" "Evaluating the Establishment and Improvement of GLP/SOP System", through the implementation of the project, the "Good Laboratory Practice for Pesticide Toxicological Safety Evaluation" was formulated. At present, our country has been accepted by the OECD as an official observer.