药品标准物质的管理与研制生产质量控制  

On Management of Pharmaceutical Reference Standards and Quality Control for Research and Production

作　　者：陈亚飞[1] 刘明理[1] 谢晶鑫[1] 赵宗阁[1] 张学博[1] 吴先富[1] 曹丽梅[1] 肖新月[1] Chen Yafei;Liu Mingli;Xie Jingxin;Zhao Zongge;Zhang Xuebo;Wu Xianfu;Cao Limei;Xiao Xinyue(National Institutes for Food and Drug Control,Beijing 102629,China)

机构地区：[1]中国食品药品检定研究院,北京102629

出　　处：《中国药事》2018年第11期1505-1510,共6页Chinese Pharmaceutical Affairs

摘　　要：目的:介绍药品标准物质管理的组织结构与研制、生产和分发中的质量控制要求,为药品标准物质的质量和供应提供更好的保障。方法:基于ISO 17034国际标准要求,梳理药品标准物质研制、生产与管理工作流程,分析研制生产与管理各环节中应控制的质量要素,强调遵循规定要求的重要性。结果:建立和完善药品标准物质研制、生产和管理的质量控制和持续供应的有效机制。结论:为确保药品标准物质的质量和可获得性,加强药品标准物质各流程环节管理很有必要。Objective： To introduce the management organization structure and quality control requirements for the research, production and distribution of pharmaceutical reference standards in order to guarantee the quality and supply. Methods： The research, production and management workflow for pharmaceutical reference standards were analyzed based on the requirements of ISO 17034 international standards. The quality factors that should be controlled in all aspects of research, production and management were also analyzed. The importance of complying with the requirements was emphasized. Results： An effective mechanism for the quality control of the research, production and distribution and continuous supply of pharmaceutical reference standards was established and improved. Conclusion： In order to ensure the quality and availability of pharmaceutical reference standards, it is necessary to strengthen the management of each process of workflow of the pharmaceutical reference standards.

关 键 词：药品标准物质 研制生产 质量控制 

分 类 号：R95[医药卫生—药学]