美国膳食补充剂良好生产规范及其制修订过程  

REVIEW OF REVISION OF CURRENT GOOD MANUFACTURING PRACTICE FOR DIETARY SUPPLEMENTS IN THE UNITED STATES

作　　者：刘奂辰[1] 张志强[2] 张立实[1] 

机构地区：[1]四川大学华西公共卫生学院营养与食品卫生学教研室,成都610041 [2]卫生部卫生监督中心

出　　处：《现代预防医学》2010年第17期3223-3225,共3页Modern Preventive Medicine

基　　金：欧盟课题;食品质量安全与控制策略-食物供应链的安全性和质量监测方法的协调(FOOD-CT2006-036337)

摘　　要：[目的]了解美国膳食补充剂良好生产规范(Current Good Manufacturing Practice for Dietary Supplements)在制修订过程中的主要变化、特点和影响,为我国相关法规的修订提供参考。[方法]收集美国食品药品监督管理局发布的各版本膳食补充剂良好生产规范,比较其主要差异及主要影响。[结果]美国的膳食补充剂良好生产规范从提议到发布历经13年,共有3个不同版本发布,从原料检验、标准操作规范、记录、召回等方面做了越来越严格的规定。[结论]在规范的修订过程中国,应尽量征求多方面的意见,尤其是中小企业的意见,以便使规范的实施更具可行性。[Objective] To know about the main differences and effects of each edition of Current Good Manufacturing Practice for Dietary Supplements in the United States, to provide references and bases for the amendment of laws in China. [Methods] Each edition of Current Good Manufacturing Practice for Dietary Supplements in the United States were collected and compared. [Results] Three editions of Good Manufacturing Practice had been published, and the latest one was the most strict. [Conclusion] Suggestions of middle and small companies should be sought to promote the specification to be carried out effectively.

关 键 词：膳食补充剂 良好生产规范 GMP 

分 类 号：R15[医药卫生—营养与食品卫生学]