国外药品生产远程检查模式介绍及启示  

Introduction and enlightenment of foreign remote inspection mode of pharmaceutical production

作　　者：史扬帆 付佳男 颜建周[1] 邵蓉[1] SHI Yangfan;FU Jianan;YAN Jianzhou;SHAO Rong(National Drug Policy and Medical Industry Economy Research Center,China Pharmaceutical University,Nanjing 211198,China)

机构地区：[1]中国药科大学国家药物政策与医药产业经济研究中心,南京211198

出　　处：《中国药房》2023年第4期385-390,共6页China Pharmacy

基　　金：教育部人文社会科学研究一般项目(No.22YJAZH126)。

摘　　要：目的为我国构建药品生产远程检查模式提供参考。方法通过梳理国外发布的远程检查指导文件和相关试点情况,总结其构建药品生产远程检查模式的经验。结果与结论国外典型国家和地区已经在世界范围内进行了远程检查试点,明确规定了药品生产远程检查的适用情形、实施流程、检查技术以及相关注意点。在适用情形方面,欧盟指出了包含旅行限制在内的4种具体适用情形,而美国则规定了远程检查适用于预批准检查等情形。在实施流程方面,美国开发了一种远程检查四步法,而欧盟则更加细致地规定了远程检查的具体实施流程,相比较下日本则更加注重对生产文件的远程检查流程。在检查技术方面,欧盟利用了360°摄像机、Matterport 3D技术和文件审查软件实现了对生产现场和生产文件的远程检查。在远程检查注意点方面,美国要求在进行信息共享时应当对信息设置访问权限以避免信息泄露,欧盟和美国均要求在展开远程检查前对检查员进行培训并对设备进行检验。建议我国出台统一的药品生产远程检查指南,明确远程检查适用情形,同时参考药品生产企业意见制定药品生产远程检查实施流程,另外还可以结合药品生产企业信息化建设水平使用智能化的远程检查技术,并且制定专门的药品生产远程检查培训方案,培养专业的远程检查团队。OBJECTIVE To provide reference for the construction of remote inspection mode of pharmaceutical production in China.METHODS By combing the guidance documents of remote inspection and related pilots issued abroad,the experience of constructing remote inspection mode of pharmaceutical production was summarized.RESULTS&CONCLUSIONS Typical foreign countries and regions have carried out remote inspection pilots all over the world,and clearly defined the application situation,implementation process,inspection techniques and related points for attention of remote inspection of pharmaceutical production.In terms of application,the European Union pointed out four specific applicable situations,including travel restrictions,while the United States stipulated that remote inspection was applicable to pre-approved inspection and so on.In terms of the implementation process,the United States developed a four-step method of remote inspection,while the European Union has defined the specific implementation process of remote inspection in more detail.In comparison,Japan paid more attention to the remote inspection process of production documents.In terms of inspection techniques,the European Union used 360°cameras,Matterport 3D technology and document review software to realize the remote inspection of production sites and production documents.In terms of attention points for remote inspection,the United States required that access rights should be set for information sharing to avoid information disclosure.Both the European Union and the United States required inspectors to be trained and equipment inspected before remote inspection.It is suggested that China should formulate unified guidelines for remote inspection of pharmaceutical production,clarify the applicable situations,and formulate the implementation process of remote inspection of pharmaceutical production with reference to the opinions of drug manufacturers.In addition,intelligent remote inspection technology can be used in combination with the information construct

关 键 词：药品生产远程检查 适用情形 实施流程 检查技术 启示 

分 类 号：R95[医药卫生—药学]