假劣药认定检验样品获取和送检中常见问题及对策  

Common Problems and Countermeasures of Obtaining and Submitting Samples for Testing of Counterfeit and Inferior Medicines

作　　者：张炜敏 梁静 黄清泉[1] 黄宝斌 ZHANG Weimin;LIANG Jing;HUANG Qingquan;HUANG Baobin(National Institutes for Food and Drug Control,Beijing,China 102629)

机构地区：[1]中国食品药品检定研究院,北京102629

出　　处：《中国药业》2022年第20期1-4,共4页China Pharmaceuticals

基　　金：中国食品药品检定研究院中青年发展研究基金[2020G1]。

摘　　要：目的为优化假劣药认定检验样品获取、储运、送检工作提供参考。方法结合假劣药认定检验受理工作经验、送检现场观察,以及通过向送检人了解的实际情况,梳理假劣药认定检验样品获取及送检中存在的常见问题,并提出对策建议。结果与结论假劣药认定检验样品存在数量及剩余有效期不足、获取方式欠规范、缺乏获取样品现场检查及相关记录和凭证、储运条件不合规、集中送检、送检准备不充分等问题。建议健全办案机关与药品检验机构的衔接协作机制,加强相关政策和技术沟通;办案机关需做好样品获取及送检相关组织保障工作,参照药品监督抽检相关要求,规范样品获取及储运,做好送检资料等准备,及时妥善送检。Objective To provide a reference for optimizing the job of obtaining,storing,transporting and submitting samples for testing of counterfeit and inferior medicines.Methods Based on the work experience of the acceptance of testing of counterfeit and inferior medicines,the on-site observation of submitting samples for test and the actual situation information from the sample submitters,the common problems in the obtaining and submission of the samples for the test of counterfeit and inferior medicines were sorted out,and the countermeasures and suggestions were put forward.Results and Conclusion There were some problems in the submitting samples for testing of counterfeit and inferior medicines,such as insufficient quantity and remaining validity period,non-standard method of obtaining samples,lack of on-site inspection and relevant records and certificates of obtaining samples,non-compliance storage and transportation conditions,centralized submitting samples,insufficient preparation for inspection,etc.It is suggested to improve the connection and cooperation mechanism between the case handling organs and the drug test institution,and strengthen the relevant policies and technical communication.The case handling organs shall do a good job in the organization and guarantee of obtaining and submitting samples for test,standardize the obtaining,storage and transportation of samples with reference to the requirements of drug supervision and sampling test,prepare the submission materials,and submit them for the test to the appropriate drug test institutes in time.

关 键 词：假劣药 认定检验 现场检查 储运 送检 药品监管 

分 类 号：R95[医药卫生—药学]