技术中心

【英文篇名】 Comparison and analysis of China's national criterion GMP(1998) and EU criterion GMP(2005)(1) 【作者中文名】 许钟麟; 张益昭; 张彦国; 潘红红; 顾维军; 孔繁慧; 【作者英文名】 Xu Zhonglin; Zhang Yizhao; Zhang Yanguo; Pan Honghong; Gu Weijun and Kong Fanhui Institute of Building Environment and Energy Efficiency; China Academy of Building Research; Beijing; China; 【作者单位】 中国建筑科学研究院; 中国医药设备工程协会; 【文献出处】 暖通空调, Heating Ventilating 中国; GMP; 比较; 分析; 【英文关键词】 EU; China; GMP; comparison; analysis; 【摘要】 从总体结构和厂房设施两大方面详细对比分析了我国1998版GMP与欧盟2005版GMP,认为我国药物生产中出现的种种质量问题和贯彻实施GMP过程中出现的不到位、不彻底的问题,并不是1998版GMP本身标准低引起的,而主要是由于某些众所周知的原因,也有设计、建造、检测、监管、维护等方面的因素。 【英文摘要】 Comprises in details the construction and facilities in pharmaceutical workshop between the two versions of good manufacturing practice.Considers that many quality problems happened in the course of medicine manufacture are due to some well-known courses,as well as design,construction,detection,management and maintenance,etc,rather than the so-called lower criterion of China's GMP(1998).