摘要
目的分析我国药品GLP关于组织机构和人员管理内容的发展变化。方法采用对比分析法,对我国1993、1999和2003年版药品GLP"组织机构和人员"一章的内容进行比较分析,同时对比分析我国2003年版GLP与美国FDA发布的GLP、经济合作与发展组织发布的GLP相关章节的内容。结果与结论我国药品GLP人员管理逐步实现标准化,但同发达国家相比仍存在一些差距,需要进一步提高。
Objective To analyze the development and changes of organization and personnel management in Chinese Pharmaceutical GLP.Methods The contents of section ＂ organization and personnel＂ in the 1993 edition,1999 edition and 2003 edition of Chinese Pharmaceutical GLP were compared.The contents on personnel management in the present edition was also compared with U.S.FDA GLP and OECD GLP.Results and Conclusion Chinese Pharmaceutical GLP personnel management was gradually standardized,but there are still some gaps with developed countries which need further improvement.
出处
《中国药事》
CAS
2012年第12期1292-1296,共5页
Chinese Pharmaceutical Affairs
关键词
药品GLP
人员管理
比较分析
pharmaceutical GLP
personnel management
comparative analysis
