中美两国GMP认证体制比较研究

目的:为我国《药品生产质量管理规范》(GMP)认证体制的完善提供借鉴。方法:采用比较法,在系统介绍中、美两国GMP认证体制的基础上,从机构性质、管理体系和机构职能等方面进行比较分析。结果与结论:通过比较发现,在2010年新版GMP实施背景下,我国GMP认证体制可适当借鉴美国的做法。通过与美国动态药品生产管理规范(cGMP)认证体制进行比较可以看出,我国GMP认证体制首先应该在认证理念方面进行转变,进一步明确GMP认证检查的目的;注重在GMP认证标准方面的一致性和独立性;注意GMP认证和制定规范的不同,确保认证的可信性;遴选非政府部门的专职GMP认证检查员,保证GMP认证的质量和可信性。

Comparative Research on GMP Certification System between United States and China

OBJECTIVE： To provide reference for the improvement of Good Manufacturing Practice for drugs （GMP） certifica- tion system in China. METHODS： GMP certification systems of the United States and China were introduced systematically and compared in respects of the nature and function of organizations and management systems. RESULTS ＆ CONCLUSIONS： Through the comparison, it could improve GMP certification system in China to adopt the experience of the United States, under the condi- tion of 2010 edition of GMP. Compared with cGMP certification systems of the United States, GMP certification system in China should change the idea of the certification firstly, further specify the purpose of the examination, and lbcus on the independence and consistency of GMP certification standard; pay attention to the difference in the practice and the establishment of GMP so as to guarantee the credibility of it; select the GMP inspectors who don＇t work for the government and ensure the quality and credibility of GMP certification.