中药材生产质量管理规范(试行)-北大法宝.DOCVIP

【CLI Code】 CLI.4.39758(EN)? Original Link： HYPERLINK /en_law/b3c762b364456c20bdfb.html \t _blank /en_law/b3c762b364456c20bdfb.html Good Agricultural Practice for Chinese Crude Drugs (Interim) 中药材生产质量管理规范(试行) Document Number：Order No. 32 of the China Food and Drug Administration Area of Law： Health and Sanitation Level of Authority： Departmental Rules Date issued：04-17-2002 Effective Date：06-01-2002 Issuing Authority： State Drug Supervision Administration Bureau (replaced) Status： Effective China Food and Drug Administration 国家药品监督管理局局令 (Order No. 32) （第32号） The Good Agricultural Practice for Chinese Crude Drugs (Interim) was passed by the State Drug Administration at the administration affairs meeting on March 18 of 2002, is hereby promulgated and shall go into effect as of June 1, 2002. 《中药材生产质量管理规范（试行）》于2002年3月18日经国家药品监督管理局局务会审议通过，现予发布。本规范自2002年6月1日起施行。 Officer: Zheng Xiaoju 局长：郑筱萸 April 17, 2002 二○○二年四月十七日 Good Agricultural Practice for Chinese Crude Drugs (Interim) 中药材生产质量管理规范（试行） Chapter I General Provisions 第一章　总则 Article 1 The Good Agricultural Practice (GAP) for Chinese Crude Drugs is formulated to regulate the production of Chinese crude drugs, ensure their quality and facilitate the standardization and modernization of traditional Chinese medicines. 　　第一条　为规范中药材生产，保证中药材质量，促进中药标准化、现代化，制订本规范。 Article 2 This GAP provides the basic principles for the production and quality management of Chinese crude drugs and is applicable to producers of Chinese crude drugs (hereinafter referred to as producers) for the entire production process of Chinese crude drugs (from plant or animal origin). 　　第二条　本规范是中药材生产和质量管理的基本准则，适用于中药材生产企业(以下简称生产企业) 生产中药材（含植物、动物药）的全过程。 Article 3 Producers should adopt standardized management and quality control to protect resources of natural crude drugs and the ecological environment, and realize sustainable utilization based on the principle of maximum sustainable yield. 　　第三条　生产企业应运用规范化管理和质量监控手段，保护野生药材资源和生态环境，坚持“最大持续产量”原则，实现资源的可持续利用。 Chap