疫苗中转仓库入库质量风险点分析及控制建议  

Quality Risk Points Found in the Inspection of Vaccine Transfer Warehouse and Its Control Suggestions

作　　者：赵瑞 夏聪华 ZHAO Rui;XIA Conghua(Zhejiang Yingte Logistics Co.,Ltd.,Hangzhou,Zhejiang,China 310015;Huadong Pharmaceutical Supply Chain Management Co.,Ltd.,Hangzhou,Zhejiang,China 310018)

机构地区：[1]浙江英特物流有限公司,浙江杭州310015 [2]华东医药供应链管理<杭州>有限公司,浙江杭州310018

出　　处：《中国药业》2019年第10期71-73,共3页China Pharmaceuticals

摘　　要：目的找出疫苗从厂家出库至中转入库过程冷链精益管理的着力点。方法以《药品经营质量管理规范》及相关规定为标准,结合实际操作经验,通过实际案例总结疫苗中转仓库入库检查中发现的质量风险点,分析可能造成的质量危害,并给出可行性建议。结果与结论当前疫苗流通过程中的硬件已基本能满足全程温控的要求,但温度记录信息间断、重要信息传递差错、单证信息不规范等管理层面的问题比较突出。当务之急是找出储运操作及管理的漏洞和疫苗精细化管理的着力点,从而进一步优化并保障流通过程中的疫苗质量。Objective To find out the key points of cold chain lean management for the process of vaccine delivery from the manufacturer to the transit to the warehouse. Methods Based on the Good Supply Practice and its related regulations,combined with practical experience,the quality risk points found in the inspection of vaccine transfer warehouse were summarized through practical cases,the possible quality hazards caused by the risk points were analyzed and feasible suggestions were put forward. Results and Conclusion The hardware conditions in the current circulation process of vaccine can basically meet the requirements of whole-process temperature control,but the management issues such as discontinuity of temperature recording information,errors of important information transmission and non-standard document information are more prominent. The urgent task is to find out the loopholes in storage and transportation operation and management,and to find out the key points of the delicacy management of vaccines,so as to further optimize and guarantee the quality of vaccines in circulation.

关 键 词：疫苗 质量风险 药品流通 医药冷链 精益管理 

分 类 号：R954[医药卫生—药学]