世界卫生组织桌面评估检查研究

Study on WHO Desk Assessment Inspection

目的为我国药品企业接受桌面评估检查提供指导,为我国药品检查方式的创新提供参考。方法分析世界卫生组织(WHO)桌面评估检查的开展依据、背景、基本程序和常见问题。结果明确了WHO桌面评估检查的程序及要求,识别出了桌面评估检查中的常见问题。结论本研究为我国药品企业接受WHO桌面评估检查提供了参考与建议,可供我国药品检查工作借鉴。

Objective To provide guidance for Chinese pharmaceutical companies to accept desk assessment inspection,and to provide reference for the innovation of drug inspection methods in China. Methods The basis,background,basic procedures and common problems of the World Health Organization( WHO) desk assessment inspection were analyzed. Results The procedures and requirements of the WHO desk assessment inspection were clarified,and common problems in the desk assessment inspection were identified.Conclusion This study provides references and suggestions for Chinese pharmaceutical companies to accept WHO desk assessment inspection,and provides a reference for China’s pharmaceutical inspection work.