摘要
目的建立国家药品标准物质库的管理规范,保证国家药品标准物质的质量与安全。方法结合国家药品标准物质库管理的实际情况,制定国家药品标准物质库管理规范。结果与结论通过建立国家药品标准物质库管理规范,使国家药品标准物质在存储环节的管理更加规范化,保障了国家药品标准物质的储藏、保管、流通、供应,保证了国家药品标准物质的质量与安全。
Objective To establish the management specification of national pharmaceutical reference standards library to guarantee the quality and safety of the national pharmaceutical reference standards.Methods The management specification was developed according to the current situation of national pharmaceutical reference standards library management.Results and Conclusion The specification can standardize the management of national pharmaceutical reference standards in storage period and ensure the quality and safety in serial points,such as storage,circulation and supplement.
出处
《中国药事》
CAS
2011年第11期1094-1096,共3页
Chinese Pharmaceutical Affairs
基金
重大新药创制-化学新药质量标准研究与评价技术平台(编号:2011ZX09303)
重大新药创制-面向新药发现的数字化中药化学成分库(编号:2011ZX09307-002-01)
关键词
国家药品标准物质库
管理规范
national pharmaceutical reference standards library
management specification
