GMP标准厂房设计探讨

Discussion on GMP Standard Plant Design

随着新药品上市许可持有人制度的实施,越来越多的双创企业、小微企业有进行小规模药品生产的需求,而建设符合GMP的厂房无论从法规具体落实、资金投入还是建设周期上都具有较大挑战。结合现医药市场大环境分析,运用多年的医药工程设计经验,整理并分析了常见的药品生产线功能及布局数据,提出了GMP标准厂房的工程建设措施。

With the implementation of the new drug market licensing system,more and more enterprises,small and medium-sized enterprises have the demand for small-scale drug production.The construction of factories that comply with GMP has great challenges in terms of specific implementation of regulations,capital investment,or construction cycle.Based on the analysis of the current medical market environment,the author collates and analyzes the functions and layout data of the common drug production line,and puts forward the construction measures of the GMP standard factory building.