“远程+现场”检查模式及监管策略  

Operation Path and Regulatory Strategy of“Limited On-site”Inspection

作　　者：张薇薇 范青峰 ZHANG Weiwei;FAN Qingfeng(Center for Inspection of JSMPA,Nanjing 210019,China)

机构地区：[1]江苏省药品监督管理局审核查验中心,江苏南京210019

出　　处：《化工管理》2023年第34期102-105,共4页Chemical Engineering Management

摘　　要：随着中国原料药制造业的发展壮大和药品监管方式的不断创新,“远程+现场”检查等新型检查模式正在逐渐兴起,该种检查模式质效高、更灵活,能够适应当前药品监管的新趋势。文章以原料药生产企业GMP符合性检查为研究对象,采用定性研究的方法,结合实际情况,探索“远程+现场”检查模式、检查内容的分配及检查流程的管理,并提出相应的监管策略。“远程+现场”检查模式的运行有助于优化药品检查资源,提升药品检查效率,对推进药品监管现代化、牢牢守住药品安全底线具有重要意义。药品监管部门需要持续完善“远程+现场”检查的相关政策,多举措保障检查的质量,及时组织技术力量开展评估。With the development and growth of China’s API manufacturing industry and the continuous innovation of drug supervision methods,new inspection models such as“limited+on-site”inspection are gradually emerging,which is of high quality and efficiency,more flexible,and can adapt to the current new trend of drug supervision.This paper takes the GMP compliance inspection of API manufacturers as the research object,adopts the qualitative research method,combined with the actual situation,explores the“limited+on-site”inspection mode,the distribution of inspection content and the management of inspection process,and puts forward the corresponding supervision strategy.The operation of the"limited+on-site"inspection mode helps to optimize drug inspection resources,improve the efficiency of drug inspection,and is of great significance to promote the modernization of drug supervision and firmly hold the bottom line of drug safety.Drug regulatory authorities need to continue to improve the relevant policies of“limited+on-site”inspection,take multiple measures to ensure the quality of inspection,and organize technical forces to carry out evaluation in a timely manner.

关 键 词：“远程+现场”检查 原料药 运行路径 监管策略 药品GMP符合性检查 

分 类 号：R95[医药卫生—药学]