国内外药品GMP监管体系对比分析

Comparative Analysis on Drug GMP Supervision Systems at Home and Abroad

目的:借鉴国外在GMP检查方面的成功经验,促进我国对药品的GMP监管。方法:分析国内外GMP检查方面的差异以及造成差异的原因。结果与结论:从六个方面提出了建议,希望对我国药品GMP监管有所帮助。

Objective： To promote the GMP supervision level at home by learning abroad successful experience. Methods： The differences in the GMP inspection between abroad and China were analyzed, and the reasons were summarized. Results and Conclusion ： Some superficial suggestions were provided from six aspects, which may he helpful to the drug GMP inspection of China in the future.