药品生产远程检查案例分析与思考  

Case Analysis and Reflection on Remote Inspection of Drug Production

作　　者：俞佳宁 颛孙燕 楼双凤 YU Jianing;ZHUAN Sunyan;LOU Shuangfeng(Shanghai Center for Drug Evaluation and Inspection,Shanghai,China 201203)

机构地区：[1]上海药品审评核查中心,上海201203

出　　处：《中国药业》2024年第15期28-31,共4页China Pharmaceuticals

摘　　要：目的 为药品监管部门开展药品生产远程检查工作提供参考。方法 梳理国内药品生产远程检查相关制度和实践案例,从企业和检查机构两方面对远程检查相关案例的风险评估、实施情况进行分析,总结远程检查要点。结果与结论 检查前,开展充分的风险评估;检查中,重视IT支持、有效沟通和风险控制;检查结束后,应保留现场检查的权利。Objective To provide a reference for drug regulatory authorities to carry out remote inspection of drug production.Methods The relevant systems and practical cases of remote inspection of domestic drug production were sorted out,the risk assessment and implementation of remote inspection-related cases from both enterprises and inspection institutions were analyzed,and the key points of remote inspection were summarized.Results and Conclusion Before the inspection,a thorough risk assessment should be conducted.During the inspection,attention should be paid to IT support,effective communication,and risk control.After the inspection,the right to conduct on-site inspections should be retained.

关 键 词：远程检查 风险评估 案例分析 药品监管 

分 类 号：R95[医药卫生—药学]