应用卫生统计学方法分析药品GSP认证检查条款  

Application of Health Statistics in Analysis on Inspection Items of Drug GSP Certification

作　　者：颜红[1] 邱鸿钟[2] 谭文艳[3] 

机构地区：[1]广东省食品药品监督管理局审评认证中心,广州510080 [2]广州中医药大学 [3]广东省医学科学院广东省人民医院广东省精神卫生研究所

出　　处：《中国药事》2012年第3期229-231,共3页Chinese Pharmaceutical Affairs

摘　　要：目的分析《药品经营质量管理规范》(GSP)认证检查条款,为GSP认证提供参考。方法采用频数分布、项目反应理论、聚类分析等卫生统计学方法,对广东省药品GSP认证现场检查缺陷项目进行分类和统计分析。结果通过3种方法的综合评价,将两种及两种以上方法一致认为对企业无评价意义的条款予以排除。结论通过对GSP认证检查条款的量化指标分析,为评价、修订GSP提供客观依据。Objective By analyzing inspection items of GSP certification,provide reference for GSP certification.Methods With application of health statistics,such as Frequency Distribution,Item Response Theory and Cluster Analysis as well,this article aims at classifying and making statistical analysis on faultiness of on-site inspection about GSP certification in Guangdong Province.Results Through a comprehensive evaluation of three methods,this article eliminate the inspection items that is considered as useless to drug Distributor evaluation via no less than two kinds of Health Statistics.Conclusion The objective basis is provided for the evaluation and revision of GSP via the quantization of index towards the inspection items of GSP certification.

关 键 词：卫生统计学 药品 药品经营质量管理规范 

分 类 号：R95[医药卫生—药学]