新冠疫情对药物非临床研究试验机构的合规性影响及应对策略  

The Impact of the COVID-19 Epidemic on the Compliance of GLP Test Facilities and the Corresponding Strategies

作　　者：李旻 王勇 赵宏哲 周婕 刘雨乐 张呈菊 汤纳平 李华 常艳 Li Min;Wang Yong;Zhao Hongzhe;Zhou Jie;Liu Yule;Zhang Chengju;Tang Naping;Li Hua;Chang Yan(Shanghai Innostar Biotechnology Co.,Ltd.,Shanghai 201203,China;Nantong Innostar Biotechnology Co.,Ltd.,Nantong 226133,China;Dalian Maritime University,Dalian 116026,China)

机构地区：[1]上海益诺思生物技术股份有限公司,上海201203 [2]益诺思生物技术南通有限公司,南通226133 [3]大连海事大学,大连116026

出　　处：《中国药事》2023年第2期157-162,共6页Chinese Pharmaceutical Affairs

基　　金：上海市科委研发平台项目(编号21DZ2291000)。

摘　　要：目的:探讨如何提升GLP试验机构应对新冠疫情所带来挑战的管理能力。方法:梳理中国、美国、OECD、英国的GLP监管政策,结合本机构2022年上海疫情实际经历,归纳GLP试验机构降低GLP遵从性的风险管控方法。结果与结论:GLP试验机构应着重预案能力的建设(如业务可持续性计划、灾难恢复计划),并从加强自身质量体系建设(如及时优化或新增标准操作规范)、强化技术人员培训等方面提升GLP试验机构管理水平,才能应对各类社会重大突发事件(如新冠疫情)和满足国内外监管机构的要求。Objective:To discuss how to improve the management capacity of GLP test facilities to cope with the challenges posed by the COVID-19 epidemic.Methods:The GLP regulatory policies of China,the United States,OECD and the United Kingdom were sorted out,and the risk management and control methods for GLP test facilities to reduce GLP compliance were summarized in combination with our actual experience of Shanghai COVID-19 epidemic in 2022.Results and Conclusion:GLP test facilities should focus on the construction of emergency response capacity(such as business continuity plan and disaster recovery plan),and improve their management level from aspects such as strengthening their own quality system construction(such as timely optimization or addition of standard operating procedures),strengthening the training of technical personnel,so as to deal with various major social emergencies(such as the new coronal epidemic)and meet the requirements of domestic and foreign regulatory agencies.

关 键 词：新冠疫情 GLP遵从性 业务可持续性计划 灾难恢复计划 

分 类 号：R95[医药卫生—药学]