国家药品标准物质保障供应综合数据平台建设
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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.
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.
引文
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[2]陈亚飞,李晓东,刘明理,等.药品标准物质基本特性与规范生产有关质量管理要求[J].中国药事,2017,31(2):134-138.
[3]曹丽梅,马双成,马玲云,等.中检所药品、医疗器械标准物质管理新模式-从分散多头管理走向集中统一管理[J].药物分析杂志,2010,30(10):1993-1995.
[4]苏丽红,姚玲文,马双成.国家药品标准物质供应工作现状与探讨[J].中国药事,2012,26(1):38-40.
[5]王丹,许明哲,马玲云,等.国内外药品标准物质的管理概况[J].中国药事,2014,28(2):185-189.
[6]曹丽梅,刘明理,赵宗阁,等.国家药品标准物质管理系统的建立及介绍[J].中国药事,2017,31(8):882-886.
[7]王雅君,赵宗阁,肖新月.国家药品标准物质标签及其说明书管理规范的建立与探讨[J].中国药事,2016,30(9):895-899.
[8]谢晶鑫,刘明理,李澄,等.国家药品标准物质的项目化管理模式研究[J].中国药师,2015,(8):1370-1371,1425.
[9]中国合格评定国家认可委员会.CNAS CL-04标准物质/标准样品生产者能力认可准则[S].2017.
[10]International Organization for Standardization.ISO 17034:2016 General Requirements for the Competence and Consistent Operation of Reference Material Producers[S].2016.
[11]陈亚飞,肖新月,李波,国外药品标准物质质量管理介绍及对我国的启示[J].中国药事,2013,27(12):1258-1261.
[12]陈亚飞,肖新月,何平,等.标准物质稳定性考察规范解读和有效期管理方式的研究[J].中国药事,2018,32(3):317-322.