安徽省药品批发企业药品质量风险管理的HACCP方法探究  

Study on HACCP method for drug quality risk management of Anhui pharmaceutical wholesale enterprises

作　　者：席永宽 张慧 黄世福 黄传华[1] 

机构地区：[1]安徽中医药大学,安徽合肥230001 [2]安徽省食品药品审评认证中心,安徽合肥230001

出　　处：《安徽卫生职业技术学院学报》2017年第2期1-3,共3页Journal of Anhui Health Vocational & Technical College

基　　金：安徽高校省级科学研究重点项目(编号:SK2013A097;SK2016A0521)

摘　　要：目的:运用科学先进的风险管理方法来加强药品批发企业的质量风险管理。方法:采取回顾性研究方法,汇总分析安徽省药品批发企业新修订GSP认证现场检查缺陷项,结合HACCP方法的相关理念,对药品批发企业进行质量风险管理方法学探究。结果:所抽取190家药品批发企业的现场检查缺陷出现频次有极大差异。结论:HACCP方法的七项原则可有效运用于药品批发企业的质量风险管理实践之中。Objective：Applying the scientific and advanced risk management method to strengthen the quality risk management of pharmaceutical wholesale enterprises.Methods：Retrospective analysis method was used to summarize and analyze the defects of Anhui pharmaceutical wholesale enterprises in the newly revised GSP certification. Combined with the related concepts of HACCP method,the method of quality risk management for pharmaceutical wholesale enterprises is explored.Results：The difference of the frequency of the occurrence of on-site inspection defects of 190 drug wholesale enterprises is great large.Conclusion：The seven principles of HACCP method can be effectively applied in the quality risk management practice of pharmaceutical wholesale enterprises.

关 键 词：风险管理 药品批发企业 HACCP方法 

分 类 号：R95[医药卫生—药学]