国家药品标准物质分装情况简介

Introduction of Current Situation of National Pharmaceutical Reference Standard Sub-packaging

目的讨论影响药品标准物质分装质量的因素。方法建立完善的质量管理体系。结果与结论应不断积累经验,归纳出不同标准物质适宜的分装方法,提高分装工作效率,确保分装质量。

Objective To investigate influence factors for sub-packaging of national pharmaceutical reference standards which have been widely used for quality control of pharmaceutical products and for the verification of instrumental parameters Methods Regulations for the process of sub-packaging were established. The key steps of sub-packaging of reference standards and the issues regarding of quality control of these substances were discussed. Results and Conclusion Suitable sub-packaging methods should be developed for each kind of reference standards which would make the substantial work of drug control more effective and efficient, and relative experience should be summarized accordingly.