美国GLP完版.docVIP

Food and Drug Administration, HHS §SOURCE: 43 FR 60013, Dec. 22, 1978, unless otherwise noted. Subpart A—General Provisions A部分——一般规定 § 58.1 Scope. 58.1范围 (a) This part prescribes good laboratory practices for conducting nonclinical laboratory studies 本部分描述了适用于非临床化验室研究的GLP， that support or are intended to support applications for research or marketing permits for 其支持或将会支持拟通过FDA批准的药品申请。 products regulated by the Food and Drug Administration, including food and color additives, 包括食品和色素添加剂 animal food additives, human and animal drugs, medical devices for human use, biological 动物食品和添加剂，人用和兽用药品，人用医疗器械 products, and electronic products. Compliance with this part is intended to assure the quality and 生物制剂和电子产品。符合本部分将会确保质量和安全数据的完整性 integrity of the safety data filed pursuant to sections 406, 408, 409, 502, 503, 505, 506, 510, 512–516, 518–520, 721, and 801 of the Federal Food, Drug, and Cosmetic Act and sections 351 and 354–360F of the Public Health Service Act. (b) References in this part to regulatory sections of the Code of Federal Regulations are to chapter I of title 21, unless otherwise noted. [43 FR 60013, Dec. 22, 1978, as amended at 52 FR 33779, Sept. 4, 1987; 64 FR 399, Jan. 5, 1999] 本部分参考21CFR I部分。 § 58.3 Definitions. 58.3定义 As used in this part, the followingterms shall have the meanings specified: 本部分用到的术语以下定义： (a) Act means the Federal Food,Drug, and Cosmetic Act, as amended(secs. 201–902, 52 Stat. 1040 et seq., asamended (21 U.S.C. 321–392)). （a）行动 意思是联邦食品、药品和化妆品行动 (b) Test article means any food additive, color additive, drug, biologicalproduct, electronic （b）检验规章 意思是任何食品添加剂、色素添加剂、药品、生物制剂、电子产品、 product, medical device for human use, or any other article subject to regulation under the act or 人用医疗器械或其他任何用于符合公共健康服务的要求或符合公共健康服务行动351和354-360部分的规定。 under sections 351 and 354–360Fof the Public Health Service Act. (c) Control article means any food additive, color additive, drug, biological product, electronic (c)控制规章 意思是任何食品添加剂、色素添加剂、药品、生