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CLP是“Good Laboratory Practice for Nonclinical Laboratory studies”的缩写,现译如本文标题,是1978年12月美国食品药物管理局(FDA)发布的,要求凡拟向FDA申请研究许可或市售许可的食品添加剂,着色剂,兽用食品添加剂,人用或兽用药物,人用医疗器材,生物制品,电子产品等,其非临床实验室研究,必须按照GLP的规定进行,如有不遵守者,FDA就取消其申请资格.规定所说的“非临床实验室研究”主要指在实验室条件下用实验模型对受试品进行的在体或离体安全试验,不包括人体试验,临床观察或动物现场验证,也不包括对受试品进行的理化性质的测定或多种利用可能性的探讨研究.GLP共含十一个部分,其中九个部分已经发布,计有:总则,组织和人员,设施、设备,实验设施的运用,受试品和对照
CLP is the acronym for “Good Laboratory Practice for Nonclinical Laboratory studies,” which is the title of this article issued by the U.S. Food and Drug Administration (FDA) in December 1978 and requires that any application for a research license or a commercial permit Food additives, coloring agents, veterinary food additives, human or veterinary drugs, human medical equipment, biological products, electronic products, etc., its non-clinical laboratory studies must be conducted in accordance with the provisions of the GLP, if non-compliance , The FDA abolished its eligibility criteria stated that the “non-clinical laboratory research” mainly refers to the experimental model of the test substance in vivo or ex vivo safety test under laboratory conditions, does not include human test, Clinical observation or animal field validation, nor does it include the physical and chemical properties of the test sample or explore the possibility of using multiple.GLP contains 11 parts, of which nine have been released, including: General, Organization and personnel, facilities, equipment, use of laboratory facilities, test subjects and controls