标准物质稳定性考察规范解读和有效期管理方式的研究-中国药事.PDFVIP

中国药事 2018年3月 第32卷 第3期 317 ·质量管理· 标准物质稳定性考察规范解读和有效期管理方式 的研究 1 1﹡ 2 1 1 1 1 1 陈亚飞 ，肖新月 ，何平 ，刘明理 ，赵宗阁 ，姚尚辰 ，谢晶鑫 ，王一平 （1. 中国食品药品检定研究院，北京 102629；2. 中国合格评定国家认可委员会，北京 100062） 摘要 目的： 解析有关标准物质稳定性研究的规范要求，探讨标准物质有效期设置的一般原则和必要性。 方法：解读有关概念和规范要求，分析预期有效期与包装和贮藏条件的关系，比较国际上不同机构对标 准物质有效期管理方式的异同。结果与结论：应按标准物质的自身属性和预期用途，科学地对标称特性 量值的稳定性和有效性进行预评估和上市后监测评估，确保标准物质的现行有效性。 关键词： 标准物质；稳定性考察要求；有效期；适宜包装；贮藏条件；稳定性监测 R927 A 1002-7777(2018)03-0317-06 中图分类号： 文献标识码： 文章编号： doi:10.16153/j.1002-7777.2018.03.004 Interpretation of Reference Material Stability Investigation Requirements and Study on Expiry Date Management Methods 1 1﹡ 2 1 1 1 1 1 Chen Yafei , Xiao Xinyue , He Ping , Liu Mingli , Zhao Zongge , Yao Shangchen , Xie Jingxin , Wang Yiping (1. National Institutes for Food and Drug Control, Beijing 102629, China; 2. China National Accreditation Service for Conformity Assessment, Beijing 100062, China) Abstract Objective: To interpret reference material stability investigation requirements and to explore the general principals and necessity of setting expiry dates. Methods: The related concepts and stability requirements were interpreted. The relationship between intended expiry dates with packaging and storage condition was analyzed. The management methods of expiry dates of different organizations worldwide were compared. Results and Conclusion: The stability of reference material and the validity of assigned value should be scientifically pre- evaluated and post-market monitored according to their intrinsic characteristics and intended use in order to insure the current validity of the reference material. Keywords ： reference material; stability investigation requirements; expi