摘要
药品是具有特殊药理毒理性质的物质。对于药品的管理,在各国药政法规中都有大量要求。如何避免药品生产中的污染和交叉污染,是药品生产管理的重点问题。从制药设施的设计和管理方面入手,对药品之间的交叉污染进行控制,是控制药品交叉污染的主要手段和关键措施。世界各国GMP和法规对制药专用设施的规定不一,导致制药技术人员对此很困惑。文章汇总了目前各国GMP对制药专用设施的要求,并结合EMA对制药专用设施的最新指南要求,对此问题进行系统研究,希望为中国制药企业提供借鉴和帮助。
Medicine is the substance with specific pharmacology and toxicology. With respect to medicine management, there are great amount of requirements in relevant regulations in many countries. How to avoid contamination and cross contamination in medicine production is fatal point in medicine production management. In design of pharmaceutical facility and management, to control cross contamination among drugs is main method and key measure to protect cross contamination. The stipulations for pharmaceutical dedicated facility described in GMP and regulations in various countries are different, thus, pharmaceutical designers may be confused. In this paper, the requirements for pharmaceutical dedicated facility stipulated in GMP in various countries were summarized, and combined with EMA, the newest guidance requirement for pharmaceutical dedicated facility was systematically studied. It is hoped that what presented herein will be helpful to Chinese pharmaceutical enterprises.
出处
《医药工程设计》
2013年第4期41-46,共6页
Pharmaceutical Engineering Design
