FOR PRESCRIPTION DRUG PRODUCTS 制造、加工、包装或者保存药品的现行良好制造规范; 总则 CURRENT GOOD MANUFACTURING PRACTICE IN MANUFACTURING, PROCESSING, PACKING, OR HOLDING OF DRUGS; GENERAL 对完成的药品的现行良好制造规范 CURRENT GOOD MANUFACTURING PRACTICE FOR FINISHED PHARMACEUTICALS 216 药房配药 PHARMACY ...
美国《联邦规章典集》（CFR）第21篇“食品与药品”总目概述：美国《联邦规章典集》（Code of Federal Regulations，CFR）第21篇“食品与药品”（Title 21―Food and Drugs）共有9卷（V olume）、3章（Chapter）、1499部（Parts）。其中：第1―8卷第1章第1―1299部，为健康与人类服务部食品与药品管理局（Food...
211 对完成的药品的现行良好制造规范 CURRENT GOOD MANUFACTURING PRACTICE FOR FINISHED PHARMACEUTICALS 216 药房配药 PHARMACY COMPOUNDING 225 对含药饲料的现行良好制造规范 CURRENT GOOD MANUFACTURING PRACTICE FOR MEDICATED FEEDS 226 对A型含药物品的现行良好制造规范 CURRENT GOOD MANUFACTURING PRACTICE FOR TYPE A ...
211 对完成的药品的现行良好制造规范 CURRENT GOOD MANUFACTURING PRACTICE FOR FINISHED PHARMACEUTICALS 216 药房配药 PHARMACY COMPOUNDING 225 对含药饲料的现行良好制造规范 CURRENT GOOD MANUFACTURING PRACTICE FOR MEDICATED FEEDS 226 对A型含药物品的现行良好制造规范 CURRENT GOOD MANUFACTURING PRACTICE FOR TYPE A ...
FOR FINISHED PHARMACEUTICALS 216 药房配药 PHARMACY COMPOUNDING 225 含药饲料的现行良好制造规范 CURRENT GOOD MANUFACTURING PRACTICE FOR MEDICATED FEEDS 226 含 A 类药品的现行良好制造规范 CURRENT GOOD MANUFACTURING PRACTICE FOR TYPE A MEDICATED ARTICLES 250 特殊人用药品的特殊要求 SPECIAL REQUIREMENTS FOR ...
211 对完成的药品的现行良好制造规范 CURRENT GOOD MANUFACTURING PRACTICE FOR FINISHED PHARMACEUTICALS 216 药房配药 PHARMACY COMPOUNDING 225 对含药饲料的现行良好制造规范 CURRENT GOOD MANUFACTURING PRACTICE FOR MEDICATED FEEDS 226 对A型含药物品的现行良好制造规范 CURRENT GOOD MANUFACTURING PRACTICE FOR TYPE A ...
美国FDA《联邦规章典集》(CFR)第21篇目录中文版 发布时间:2010-5-1113:44:12发布方:奥咨达医疗器械咨询 美国《联邦规章典集》(CFR)第21篇“食品与药品”总目 概述:美国《联邦规章典集》(CodeofFederalRegulations,CFR)第21篇“食品与药品(”Title21―FoodandDrugs)共有9卷(Volume)、 3章(Chapter)、1499部(Pa...
100 总则 GENERAL101 食品标识 FOOD LABELING102 非标准化食品的普通的或者通常的名称 COMMON OR USUAL NAME FOR NONSTANDARDIZED FOODS104 食品的营养质量指南 NUTRITIONAL QUALITY GUIDELINES FOR FOODS?105 特殊膳食用途的食品 FOODS FOR SPECIAL DIETARY USE106 婴儿配方母乳替代食品质量控制程序 INFANT FORMULA QUALITY...
Part 211 –Current Good Manufacturing Practice for Finished Pharmaceuticals: Provides the minimum current good manufacturing practice for preparation of drug products for administration to humans or animals. Part 820 –Quality System Regulation: Describes the requirements that govern th...
INTRODUCTION The US good manufacturing practices guidelines for finished pharmaceuticals (GMPs) (1) were formally introduced in 1963 (2) based upon the best practices of the US Food and Drug Administration ...