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2011年3月17日发布的我国新药品GMP,在硬件、软件各方面都推出了新标准、新要求、新概念、新措施。为配合宣贯新GMP,中国建筑科学研究院许钟麟研究员修订出版了《药厂洁净室设计、运行与GMP认证》(第2版)一书,详细分析了新GMP对药厂总图设计、平面布置、系统划分、防止污染的要求,提出了相应措施,特别对无菌药品
March 17, 2011 release of China’s new drug GMP, in all aspects of hardware and software have introduced new standards, new requirements, new concepts, new measures. To tie in with the announcement of the new GMP, Xu Zhonglin, a researcher at China Academy of Building Research, revised and published “The Design, Operation and GMP Certification of Cleanrooms in Pharmaceutical Plants” (2nd Edition), which analyzes in detail the new GMP’s master plan for pharmaceutical plants, Arrangement, system division, to prevent pollution requirements, put forward the corresponding measures, especially for sterile drugs