中美药品GMP检查体系对比分析

目的为完善我国药品GMP检查体系提出建设性意见。方法对中美药品GMP检查体系进行系统对比分析,借鉴美国的经验,结合中国实际,提出意见建议。结果美国药品GMP检查体系在法律法规、检查机构管理模式、GMP培训、检查员和专家队伍、现场检查管理制度等方面具有显著特点,值得我国借鉴。结论完善法律法规、调整认证检查机构设置与职能分配、加强非GMP认证药品生产现场相关检查人员GMP知识的培训、建立专职检查员与现场检查专家队伍、完善现场检查管理制度,将有利于我国药品GMP检查体系的完善。

Comparative Analysis Between China and U.S.Drug GMP Inspection Systems

Objective To offer the constructive advice on the development of the China drug GMP inspection system. Methods U.S. GMP inspection system was compared with China GMP inspection system and some advice was put forward with reference of experience in U. S. in combination with China＇s realities. Results U.S. GMP inspection system has advantages in many aspects such as laws and regulations, management mode of GMP inspection department, GMP training, team of inspectors and specialists, and on-site GMP inspection, which are worth recommending to our nation. Conclusion The Chinese drug GMP inspection system can be improved through measures such as improvement of legal system for GMP inspection, adjustment of GMP inspection department organization and function distribution, strengthenment of GMP training for staff conducting on-site inspection of non GMP certification, establishment of the full-time inspector team and the specialist team for on-site inspection, perfection of management rules for on-site inspection.