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安徽省药品流通质量风险分级管理评价研究
黄传华,席永宽,张慧,魏骅
0
(安徽中医药大学;安徽省食品药品审评认证中心)
摘要:
在流通环节对药品进行分级管理有助于药品质量风险的控制。在对安徽省药品批发企业质量管理风险进行调研的基础上,运用卡方检验进行缺陷项的差异性检验,并对缺陷项差异性进行排序,确定风险等级。在缺陷项确定的基础上进行风险点的识别,运用FMEA法进行风险评估与控制对策研究。研究发现在批发企业药品质量风险管理中,有意识进行风险识别与控制,加强设施设备检查维护,强化质量管理员的业务培训以及完善药品质量信息的存档管理显得非常重要。
关键词:  药品流通  质量风险管理  风险分级  SPSS
DOI:
基金项目:安徽省高校人文社会科学研究重大项目“安徽省促进中药产业健康发展政策研究”(SK2017ZD18);安徽省高校人文社会科学研究重点项目“基于健康中国建设的互联网医药营销模式研究”(SK2016A0521)
Evaluation of Level to Level Management of Drug Circulation Quality Risk in Anhui Province
HUANG Chuanhua,XI Yongkuan,ZHANG Hui,WEI Hua
(Anhui University of Chinese Medicine;Evaluation and Certification Center for Food and Drug of Anhui Province)
Abstract:
The leveltolevel management in drug circulation is helpful for drug quality risk control. Based on the investigation of Anhui drug wholesalers, this paper studied the differentness of defective items with the chisquare test, ranked them, determined their risk levels, identified risk points, evaluated risks and proposed control countermeasures. The results show that it is important for drug wholesalers, in drug quality risk management, to consciously conduct risk identification and control, strengthen facilities and equipment inspection and maintenance, intensify quality controllers’ professional training, and improve the management of drug quality information archive.
Key words:  drug circulation  quality risk management  risk grading  SPSS

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