药品流通领域挂靠走票现象的剖析及监督检查方法  

Analysis of the Affiliated Ticket Circulation Phenomenon in Drug Circulation Field and the Supervision and Inspection Method

作　　者：郭红军 

机构地区：[1]吉林省食品药品认证中心,长春130062

出　　处：《中国药事》2017年第9期1021-1025,共5页Chinese Pharmaceutical Affairs

摘　　要：目的:探讨针对药品经营企业挂票走票问题的GSP飞行检查方法。方法:对吉林省食品药品监督管理局2016年组织的GSP飞行检查中有关挂靠走票企业被撤销药品GSP证书,或药品经营许可证检查报告中的缺陷条款进行统计分析;邀请在被撤证企业参与现场检查的检查员、全省GSP检查组长级检查员、吉林省食品药品认证中心药品流通认证检查科全体人员参加讨论研究,得出结论。结果:根据企业挂靠走票存在的各种现象,归纳出具有科学性策略的检查方法。结论:研究出的检查方法科学准确、针对性强、简便快捷,值得在药品GSP飞行检查中推广。Objective： To discuss GSP flight inspection method for the affiliated ticket circulation in pharmaceutical enterprises. Methods： The defective provisions from the inspection reports on the enterprises whose drug GSP certificates or pharmaceutical trading licenses were revoked due to the affiliated ticket circulation during the GSP flight inspections organized by Jilin Province Food and Drug Administration in 2016 were analyzed. All inspectors participating in the on-site inspection of the enterprises, GSP inspection team leaders of Jilin Province, as well as all the staff in Division of Medicine Circulation Certification Inspection of Jilin Certification Center for Food and Drug participated in the discussion and drew a conclusion. Results： A scientific inspection method was summarized according to various phenomena of affiliated ticket circulation. Conclusion：The inspection method was scientific and accurate, specific and pertinent, simple and quick, and worthy of popularizing in the drug GSP flight inspection.

关 键 词：GSP飞行检查 挂靠走票 检查方法 

分 类 号：R954[医药卫生—药学]