摘要
目的为疫苗驻厂检查工作提供参考。方法通过结合派驻期间工作体会,分析驻厂检查员须具备的能力素质及检查工作开展模式。结果和结论疫苗驻厂检查是有效的监管手段。为进一步做好驻厂检查工作,建议加强检查员的培训与考核,并加快推进药监系统智慧监管平台建设。
OBJECTIVE To offer reference for resident inspection of the vaccine.METHODS Analyze the ability and competence of the resident inspector and the mode of inspection work based on the work experience during the inspection period.RESULTS and CONCLUSION The resident inspection of the vaccine is an effective regulatory mean.In order to further improve the resident inspection,it is recommended to strengthen the training and assessment of inspectors and accelerate the construction of a smart supervision platform for the drug supervision system.
作者
王馨
张鑫
WANG Xin;ZHANG Xin(Fujian Institute for Food and Drug Quality Control,Fuzhou 350001,China;Fujian Provincial Center for Drug Inspection,Fuzhou 350001,China)
出处
《海峡药学》
2022年第8期165-167,共3页
Strait Pharmaceutical Journal
关键词
疫苗
驻厂检查
监管
Vaccine
Resident inspection
Supervision