全球制药行业厂房与设施、设备类检查缺陷情况分析

目的 为我国药品监管和行业发展提供参考。方法 对近几年FDA、MHRA、CFDI及辽宁省药品GMP检查中厂房与设施、设备类的缺陷进行统计分析，从缺陷占比、高频缺陷等角度分析GMP检查缺陷在反映制药企业硬件水平方面的重要作用。结果与结论 从GMP检查缺陷角度发现了我国制药行业和发达国家的差距，为我国制药行业在厂房与设施、设备方面改进提出了建议。

Analysis of Inspection Deficiencies of Buildings and Facilities, Equipment of Pharmaceutical Industry Worldwide

Objective: To provide reference for drug supervision and industry development in China. Methods: The GMP inspection deficiencies about buildings and facilities, equipment which were issued by FDA, MHRA, CFDI and Liaoning drug regulatory agency in recent years were analyzed, and the important role of GMP inspection deficiencies in reflecting the hardware level of pharmaceutical enterprises was analyzed from the perspective of deficiency proportion and high frequency deficiencies. Results and conclusion: The gap between China and developed countries in buildings and facilities, equipment is found from the perspective of GMP inspection deficiencies. Suggestions are put forward for the improvement of buildings and facilities, equipment of China''s pharmaceutical industry.