我国特殊医学用途配方食品GMP与药品GMP的比较.pdf

494 我国特殊医学用途配方食品GMP与药品GMP的 比较 1 1* 2* （1. 酵母功能湖北省重点实验室，宜昌 443003；2. 中国疾病预防控 陈智仙 ，张彦 ，张双庆 制中心营养与健康所，北京 100050） 摘要 目的： 方 对特殊医学用途配方食品企业良好生产规范和药品生产质量管理规范进行比较研究。 法：对两种生产规范从编写思路、厂房及设施、质量控制和质量管理、人员及管理制度、记录与文件管 理、原料和包装材料等方面的异同进行比较。结果与结论：通过分析和比较，有利于医务人员、生产企 业及相关从业人员了解特殊医学用途配方食品企业良好生产规范及相关配套法规和标准完善的必要性， 更好地了解特殊医学用途配方食品和药品的生产要求，更好地区分二者的异同，避免混淆。 关键词： 特殊医学用途配方食品；药品；GMP；比较 R95 A 1002-7777(2018)04-0494-08 中图分类号： 文献标识码： 文章编号： doi:10.16153/j.1002-7777.2018.04.012 Comparison Between GMP of Foods for Special Medical Purpose and Drug GMP 1 1* 2* Chen Zhixian , Zhang Yan , Zhang Shuangqing (1. The Hubei Provincial Key Laboratory of Yeast Function, Yichang 443003, China; 2. National Institute for Nutrition and Health, Chinese Center for Disease Control and Prevention, Beijing 100050, China) Abstract Objective: To compare the GMP of foods for special medical purpose (FSMP) with drug GMP. Methods: The similarities and differences of the two types of GMPs were compared from the following aspects, writing ideas, plants and facilities, quality control and management, personnel and management system, records and document management, raw materials and packaging materials and so on. Results and Conclusion: The analysis and comparison were beneficial for medical personnel, manufacturing enterprises and relevant practitioners to understand the necessity of improving relevant laws and regulations and perfecting standards of enterprises producing FSMP so as to better understand the production requirements and differences of FSMP and drugs and to avoid confusion. Keywords: foods for special medical purpose; drug; GMP; comparison 特殊医学用途配方食品，是指为满足进食受 下，单独食用或与其他食品配合食用[1] 。它本质是 限、消化吸收障碍、代谢紊乱或特定疾病状态人群