药品远程非现场检查开展模式研究  

Research on the Mode of Remote Off-site Drug Inspection

作　　者：王鼎峰 林红 陈航 何沁雪 吴春敏 WANG Ding-feng;LIN Hong;CHEN Hang;HE Qin-xue;WU Chun-min(Fujian Center for Drug Inspection,Fuzhou 350003,China)

机构地区：[1]福建省药品审核查验中心,福建福州350003

出　　处：《海峡药学》2023年第9期108-110,共3页Strait Pharmaceutical Journal

基　　金：福建省药品监督管理局科技项目“药品远程非现场检查开展模式探讨”(项目编号2022003)。

摘　　要：目的为探索药品检查新途径提供新模式、新方法,为远程非现场检查工作不断完善积累经验和作法,以提高依申请检查的效率。方法结合药企申请事项的特点,合理应用“远程检查”和“远程+现场检查”两种方式,将风险跟踪、识别、评估、控制的理念引入到药品生产检查全过程,有条不紊、循序渐进地组织开展远程非现场检查工作。结果通过对不同申请事项、不同检查方式的学习和实战,发挥“互联网+”技术在“线上”+“线下”检查工作中的实际应用,为进一步落实和推广远程非现场检查工作积累经验与作法。结论通过对国内外药品监管机构的非现场检查指南的研究分析,以过程风险预防控制为导向,持续更新检查应关注的风险点,进一步提高药品远程检查的指向性、科学性、计划性,探索如何建立药品远程非现场检查模式。OBJECTIVE To provide new models and methods for exploring new ways of drug inspection,accumulate experience and practice for continuous improvement of remote off-site inspection,and improve the efficiency of inspection according to application.METHODS According to the characteristics of application by the pharmaceutical enterprise,the two methods of“remote inspection”and“remote plus on-site inspection”were reasonably applied,and the concept of risk tracking,identification,evaluation and control was introduced into the whole process of drug production inspection,and the remote off-site inspection work was organized in an orderly and gradual manner.RESULTS Through the study and practice of different application and different inspection methods,“Internet plus”technology was utilised in“online”+“offline”inspection work,and experience and practice were accumulated for further implementation and promotion of remote off-site inspection work.CONCLUSION Through the research and analysis of the off-site inspection guidelines of domestic and foreign drug regulatory agencies,guided by the process risk prevention and control,the risk points that should be paid attention to in the inspection should be continuously updated,and the directionality,scientificity and planning of the remote inspection of drugs should be further improved,and how to establish the remote off-site inspection mode of drugs should be studied.

关 键 词：药品检查 远程非现场 检查模式 

分 类 号：R969.4[医药卫生—药理学]