浏览全部资源
扫码关注微信
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
- 中国药房 2023年34卷第4期 页码：385-390
- 作者机构：
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
- 作者简介：
硕士研究生。研究方向：医药政策与法规。电话：025-86185038。E-mail：1647056523@qq.com
教授，博士生导师，博士。研究方向：医药政策与法规。电话：025-86185038。E-mail：shaorong118@163.com
- 基金信息：教育部人文社会科学研究一般项目(22YJAZH126)
DOI：10.6039/j.issn.1001-0408.2023.04.01
中图分类号： R95收稿日期：2022-08-09，
修回日期：2022-09-20，
纸质出版日期：2023-02-28
- 稿件说明：
移动端阅览
史扬帆,付佳男,颜建周,等.国外药品生产远程检查模式介绍及启示[J].中国药房,2023,34(04):385-390.
SHI Yangfan,FU Jianan,YAN Jianzhou,et al.Introduction and enlightenment of foreign remote inspection mode of pharmaceutical production[J].ZHONGGUO YAOFANG,2023,34(04):385-390.
史扬帆,付佳男,颜建周,等.国外药品生产远程检查模式介绍及启示[J].中国药房,2023,34(04):385-390. DOI： 10.6039/j.issn.1001-0408.2023.04.01.
SHI Yangfan,FU Jianan,YAN Jianzhou,et al.Introduction and enlightenment of foreign remote inspection mode of pharmaceutical production[J].ZHONGGUO YAOFANG,2023,34(04):385-390. DOI： 10.6039/j.issn.1001-0408.2023.04.01.
摘要
目的
2
为我国构建药品生产远程检查模式提供参考。
方法
2
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
2
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。
Abstract
OBJECTIVE
2
To provide reference for the construction of remote inspection mode of pharmaceutical production in China.
METHODS
2
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
2
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 construction level of drug manufacturers， and remote inspection training program can be formulated to cultivate professional remote inspection team.
关键词
Keywords
references
闫兆光 ， 白鹤 ， 李玉基 ， 等 . 关于健全药品生产检查体系科学准确定位各类检查重点的思考 [J ] . 中国食品药品监管 ， 2021 （ 7 ）： 42 - 49 .
MOFID S ， BOLISLIS W R ， BRADING C ， et al . The uti-lity of remote inspections during the COVID-19 health emergency and in the postpandemic setting [J ] . Clin Ther ， 2021 ， 43 （ 12 ）： 2046 - 2063 .
EMA . Remote pharmacovigilance inspections of MAHs during a crisis situation：points to consider [EB/OL ] .（ 2012-12-14 ）[ 2022-05-25 ] . https：//www.ema.europa.eu/en/documents/regulatory-procedural-guideline/remote-pharmacovigilance-inspections-mahs-during-crisis-situation-points-consider_en.pdf https://www.ema.europa.eu/en/documents/regulatory-procedural-guideline/remote-pharmacovigilance-inspections-mahs-during-crisis-situation-points-consider_en.pdf .
European Directorate for the Quality of Medicines . EDQM and real-time remote GMP inspections of API manufacturers during the COVID-19 pandemic：innovation overcoming adversity [EB/OL ] .（ 2022-03-20 ）[ 2022-05-25 ] . https：//www.edqm.eu/en/edqm-and-real-time-remote-gmp-inspections-of-api-manufacturers-during-the-covid-19-pandemic-innovation-overcoming-adversity https://www.edqm.eu/en/edqm-and-real-time-remote-gmp-inspections-of-api-manufacturers-during-the-covid-19-pandemic-innovation-overcoming-adversity .
FDA . Remote interactive evaluations of drug manufactu-ring and bioresearch monitoring facilities during the COVID-19 public health emergency [EB/OL ] .（ 2021-04-14 ）[ 2022-05-25 ] . https：//ecompliance.co.jp/FDA/Remote-Interactive-Evaluations-of-Drug-Manufacturing-Establish-ments_J.pdf https://ecompliance.co.jp/FDA/Remote-Interactive-Evaluations-of-Drug-Manufacturing-Establish-ments_J.pdf .
National Science Foundation . Pharmaceutical remote audit process [EB/OL ] .（ 2020-04-02 ）[ 2022-05-25 ] . https：//www.nsf.org/knowledge-library/pharmaceutical-remote-audit-process https://www.nsf.org/knowledge-library/pharmaceutical-remote-audit-process .
EMA . Guidance related to GMP/GDP and PMF distant assessments . A GMP/GDP distant assessment guidance：version 1[EB/OL ] .（ 2020-10-15 ）[ 2022-05-25 ] . https：//www.ema.europa.eu/en/documents/scientific-guideline/guidance- related-gmp/gdp-pmf-distant-assessments_en.pdf https://www.ema.europa.eu/en/documents/scientific-guideline/guidance-related-gmp/gdp-pmf-distant-assessments_en.pdf .
PMDA . Procedure for remote inspection as a part of compliance inspection on drugs and regenerative medical pro-ducts [EB/OL ] .（ 2020-12-16 ）[ 2022-05-25 ] . https：//www.pmda.go.jp/files/000238733.pdf https://www.pmda.go.jp/files/000238733.pdf .
CHAPMAN J . A state-of-the-art virtual inspection metho-dology using mixed reality technology gets high marks from European medicines agency inspector [EB/OL ] .（ 2020-06-09 ）[ 2022-05-25 ] . https：//redica.com/pharma-medical-devices-a-state-of-the-art-virtual-inspection-metho-dology-using-mixed-reality-technology-gets-high-marks-from-european-medicines-agency-inspector/ https://redica.com/pharma-medical-devices-a-state-of-the-art-virtual-inspection-metho-dology-using-mixed-reality-technology-gets-high-marks-from-european-medicines-agency-inspector/ .
林凡钰 ， 梁佳琪 ， 李宗阳 ， 等 . 非现场检查工作挑战及美欧经验借鉴研究 [J ] . 中国食品药品监管 ， 2021 （ 6 ）： 48 - 57 .
浙江省药品监督管理局 . “浙苗链”“黑匣子”正式上线 [EB/OL ] .（ 2021-04-15 ）[ 2022-05-25 ] . http：//mpa.zj.gov.cn/art/2021/4/15/art_1228989351_58925155.html http://mpa.zj.gov.cn/art/2021/4/15/art_1228989351_58925155.html .
河南省药品监督管理局 . 省药监局召开会议强力推进药品生产智慧监管“千里眼工程” [EB/OL ] .（ 2021-12-20 ）[ 2022-05-25 ] . http：//yjj.henan.gov.cn/2021/12-27/23720-14.html http://yjj.henan.gov.cn/2021/12-27/23720-14.html .
金华市人民政府 . 我市创新上线药品智慧检查系统 [EB/OL ] .（ 2021-08-09 ）[ 2022-05-25 ] . http：//www.jinhua.gov.cn/art/2021/8/9/art_1229159979_60217130.html http://www.jinhua.gov.cn/art/2021/8/9/art_1229159979_60217130.html .
霍凤兰 . 稳步推进药品生产非现场监管信息系统试点建设 [J ] . 中国食品药品监管 ， 2011 （ 8 ）： 30 - 31 .
朱明 ， 常丽梅 ， 符祝 ， 等 . 移动互联网技术用于药品注册现场检查实践与效果 [J ] . 中国药业 ， 2019 ， 28 （ 22 ）： 68 - 70 .
王丹 ， 欧阳楠 ， 陈颖 . 省级职业化药品检查员队伍构建现状分析 [J ] . 中国药业 ， 2021 ， 30 （ 2 ）： 11 - 14 .
0
浏览量
247
下载量
0
CSCD
- 网络PDF下载
- WORD下载
- Meta-XML下载
- BibTeX下载
- Endnote下载
- RefMan 下载
- NoteExpress下载
- NoteFirst下载
关联资源
相关文章
相关作者
相关机构
- 技术支持由北京北大方正电子有限公司提供 京ICP备09064830号-19
京公网安备11010802024621 - 本系统建议在Chrome、 IE9+ 以上版本浏览器阅读本站内容，360浏览器请切换至极速模式
- Cookies帮助我们提供服务并提供个性化体验。使用本网站，即表示您同意我们使用Cookies
