从我国药品GMP内容的变化看人员管理的动向

Study the Trend of Personnel Management According to the Changes in Chinese Pharmaceutical GMP

目的分析我国药品GMP人员管理内容的变化及发展动向。方法采用比较研究的方法,对我国药品GMP 92版、现行版和修订版"机构与人员"一章的内容进行比较分析,以发现我国药品GMP人员管理内容的变化;同时对比修订版GMP与欧盟、WHO药品GMP的相关规定,以评价我国药品GMP人员管理的发展水平。结果与结论我国药品GMP人员管理的内容通过不断调整与提高,正朝着更加全面、标准化、国际化的方向发展。

Objective To research the changes and the trend of personnel management in Chinese pharmaceutical GMP.Methods Compare the contents of part ＂organization and personnel＂ in the 92 edition,the current edition and the revised edition of Chinese pharmaceutical GMP to discover the changes on personnel management.Compare the contents on personnel management in the revised edition to that of the EU GMP,WHO GMP to find the development level of personnel management in Chinese pharmaceutical GMP.Results and Conclusion The regulations on personnel management in Chinese pharmaceutical GMP are richer,more standardized and more international through being revised.