摘要
目的对药品上市许可持有人和受托检验机构执行药品委托检验要求提出改进措施,为加强药品委托检验管理提供对策建议。方法采取文献调查法、问卷调查法、回顾研究分析法,以2021年6月至2022年7月江西省开展的98家次药品委托检验检查情况为研究对象,对检查发现的缺陷项目进行了统计分析。结果共汇总缺陷82项,其中主要缺陷共8项,一般缺陷74项,主要集中在物料审核放行、受托检验机构考察评估、委托检验协议签订、样品的代表性、受托检验机构质量管理体系建设等方面。结论药品上市许可持有人应当加强人员培训,强化药品委托检验有效性管理;受托检验机构应当严格履行委托检验协议的各项要求,完善自身质量体系建设,确保检验数据真实、准确。建议药品监管部门建立药品委托检验信息共享联动机制,坚持监检结合,强化日常管理,出台优化检验资源配置利用的政策,实现监管和效益的双赢。
Objective To Propose improvement measures for marketing authorization holder and entrusted inspection institutions to implement drug entrusted inspection requirements,and provide countermeasures and suggestions for strengthening drug entrusted inspection management.Methods Literature review,questionnaire survey and retrospective research analysis methods were adopted,and the results of the 98 entrusted inspection carried out in Jiangxi Province from June 2021 to July 2022 were taken as the research objects,and statistical analysis on the defects found in the inspection were conducted.Results A total of 82 inspection defects were found,including 8 major defects and 74 general defects,which were mainly in the aspects of material review and release,inspection and evaluation of inspection agencies,signing the inspection agreement,the representative of sample,and the construction of the quality management system of inspection agencies.Conclusion The marketing authorization holder should strengthen the training of personnel and the effective management of drug commission inspection;the inspection institution should strictly fulfill the requirements of the entrusted inspection agreement,improve the construction of its own quality system,and ensure that the inspection data is true and accurate.It is recommended that the drug regulatory department establishes a linkage mechanism for the inspection information sharing of drug commission,adheres to the combination of supervision and inspection,strengthen daily management,introduces the policy of optimizing the allocation and utilization of the inspection resource,and achieves a win-win situation of supervision and benefits.
作者
杜传龙
王子千
孙西军
廖辉军
付文艳
DU Chuanlong;WANG Ziqian;SUN Xijun;LIAO Huijun;FU Wenyan(Jiangxi Drug Inspection Center,Nanchang Jiangxi 330029,China;Jiangxi Provincial Drug Administration,Nanchang Jiangxi 330029,China;The Second Affiliated Hospital of Nanchang University,Nanchang Jiangxi 330001,China)
出处
《药品评价》
CAS
2023年第11期1305-1310,共6页
Drug Evaluation
基金
江西省药品监督管理局科研项目(2021KY27)。
关键词
药品上市许可持有人
委托检验
受托检测机构
监管策略
Marketing authorization holder
Entrusted inspection
Third party testing institutions
Regulatory strategies
