河南省药品批发企业GSP监督检查储存与养护缺陷项目分析

Analysis of Storage and Maintenance Defective Items in Drug Wholesale Enterprises under the Supervision and Inspection of GSP in Henan Province

目的:通过对2020-2022年河南省药品批发企业GSP监督检查中储存与养护环节的共性问题进行分析,为药品批发企业规范开展储存与养护工作提供建议。方法:对2020-2022年河南省GSP监督检查的药品批发企业存在的缺陷进行汇总,通过Apriori算法寻找各缺陷项目与储存与养护章节下缺陷项目的相关性,统计分析药品储存与养护章节存在的问题,并提出建议。结果:储存与养护缺陷在药品批发企业缺陷中出现的频次最高,主要缺陷*08308、一般缺陷08405出现的频次高、占比大,一般缺陷06501、08305与04603的相关性需要引起重视。结论:药品批发企业应强化自身主体责任意识,加强人员岗位培训,建立健全质量管理体系与制度,借助科学技术规范开展经营活动。药品储存与养护的从业人员应增强法律意识,遵守职业道德,保障药品质量安全,促进药品流通行业持续健康发展。

Objective:To provide suggestions for drug wholesale enterprises to carry out storage and maintenance work in a standardized manner by analyzing the common issues in the storage and maintenance process during the supervision and inspection of GSP of drug wholesale enterprises in Henan Province from 2020 to 2022.Methods:The deficiencies of drug wholesale enterprises under the supervision and inspection of GSP in Henan Province from 2020 to 2022 were summarized,the correlation between each defective item and the defective items under the storage and maintenance chapter was found by Apriori algorithm,and the problems in the chapter on drug storage and maintenance were statistically analyzed,and suggestions were put forward.Results:Storage and maintenance defective items had the highest frequency among defects in drug wholesale enterprises,with major defective item*08308 and general defective item 08405 occurred more frequently and accounted for a larger proportion,the correlation between general defective items 06501,08305 and 04603 needed to be taken seriously.Conclusion:Drug wholesale enterprises should strengthen their sense of main responsibility,strengthen personnel job training,establish and improve quality management systems,and carry out business activities with the help of scientific and technological norms.Drug storage and maintenance practitioners should enhance legal awareness,abide by professional ethics,thus better ensure drug quality and safety,and promote the sustained and healthy development of the drug distribution industry.