关键词: 药品检查, 预认证, 世界卫生组织, 药品生产质量管理规范

Abstract: Analyzed the WHO technical guidelines and basic procedures of drug inspection， and conducted a statistical analysis on the WHO inspection situations and observations of Chinese drug manufacturers in recent years. Based on these analyses， the WHO technical guidelines structure frameworks and basic inspection procedures of drug inspection are further clarified， and the distribution of major observations and common problems existing in WHO inspection of Chinese drug manufacturers are identified.It provides reference for improving the quality management abilities of Pharmaceutical Industry， and providesimprovement directions and suggestions for pharmaceutical manufacturers to undergo WHO inspections successfully.

Key words: Druginspection, Prequalification, World Health Organization（WHO）, Good manufacture practice（GMP）