摘要
目的:为提高国家药品抽检样品受理的效率提出相应建议。方法:根据2018年度国家药品抽检工作在样品接收和受理登记环节中遇到的问题,分析问题产生的原因,从而提出解决问题的办法。结果与结论:建议各抽样机构认真解读《国家药品抽检工作手册》,严格执行国家药品抽检实施方案的抽样要求;抽样人员按照方案中的抽样数量抽取样品,按样品说明书要求的储藏条件保存和寄运;受理登记人员在受理审核环节严格把关,确保样品信息的准确无误。
Objective:To put forward some suggestions to improve the registration efficiency of national drug sampling inspection.Methods:To summarize the problems encountered in the process of sample receiving and registration of national drug sampling inspection of NIFDC in 2018,analyze the causes of the problems,and then propose solutions to the problems.Results and Conclusion:It is suggested that all sampling institutions should seriously interpret the national drug sampling inspection manual and strictly implement the detailed contents in the sampling requirements of the national drug sampling inspection implementation plan.Sampling personnel should take samples according to the sample quantity in the plan,and the samples should be transported by post according to their storage and transportation conditions specified in the sampling instructions;Registration personnel should check strictly to ensure that the sample information is accurate.
作者
高芳
梁静
杨玥莹
王敬
董红环
黄清泉
Gao Fang;Liang Jing;Yang Yueying;Wang Jing;Dong Honghuan;Huang Qingquan(National Institutes for Food and Drug Control,Beijing 102629,China)
出处
《中国药事》
CAS
2020年第6期632-635,共4页
Chinese Pharmaceutical Affairs
关键词
国家药品抽检
抽样
受理登记
national drug sampling inspection
sampling
registration
