国家药品标准物质保障供应综合数据平台建设  

Establishment of Comprehensive Data Platform to Guarantee the Supply of National Drug Reference Standards

作　　者：谢晶鑫[1] 刘明理[1] 王昆[1] 傅瑶 曹丽梅[1] 肖新月[1] Xie Jingxin;Liu Mingli;Wang Kun;Fu Yao;Cao Limei;Xiao Xinyue(National Institutes for Food and Drug Control,Beijing 100050,China)

机构地区：[1]中国食品药品检定研究院,北京100050

出　　处：《中国药事》2019年第1期16-20,共5页Chinese Pharmaceutical Affairs

摘　　要：目的:进一步提高国家药品标准物质供应保障的能力和水平,更好支撑药品监管需求和服务行业发展。方法:将信息化管理和分析方法与现有的标准物质管理技术要求相结合,研究建立数字化、可视化的数据共享系统。结果:建成的国家药品标准物质保障供应综合数据平台,可显示各品种的研制生产阶段和效率。结论:该平台试运行一年来已成为指导研制、生产和管理的有力抓手,为对接国际标准ISO 17034奠定了重要基础。Objective:To further improve the capability and level of the national drug reference standards supply in order to better meet the drug regulatory requirements and ensure the development of the industry.Methods:Informatization management and data analytic methods were combined with current technical requirements for reference standards’management to establish a digital and visual data-sharing system.Results:The established comprehensive data platform to guarantee the supply of national drug reference standards can display the stages of development and production and efficiency of all kinds.Conclusion:The platform has been a powerful measure to guide the development,production and management in the first year of trial operation,laying an important foundation for the connection with ISO 17034.

关 键 词：药品 标准物质 研制生产过程 信息化管理 数据平台 

分 类 号：C931.6[经济管理—管理学] R95[医药卫生—药学]