PIC/S实时放行检测相关要求的研究与借鉴  

PIC/S Requirements for Real-time Release Testing and the Referential Significanceto China

作　　者：徐赜 楼双凤 李香玉 Xu Ze;Lou Shuangfeng;Li Xiangyu(Shanghai Center for Drug Evaluation and Inspection,Shanghai 201203,China)

机构地区：[1]上海药品审评核查中心,上海201203

出　　处：《中国药事》2023年第5期513-519,共7页Chinese Pharmaceutical Affairs

摘　　要：目的:通过分析药品检查合作计划(PIC/S)药品生产质量管理规范(GMP)指南及实时放行检测(RTRT)附录的要求,为我国制药行业实时放行检测技术的发展和应用提供思路和建议。方法:对PIC/S的GMP指南及RTRT附录进行深入研究,并结合国内外RTRT相关法规、文献,探讨RTRT在我国制药行业的可行性及对我国药品监管的启示。结果与结论:建议我国药监部门尽早对标PIC/S相关技术要求,结合参数放行的试点经验及我国制药行业发展特点,出台符合国情的RTRT指南,保障RTRT在我国制药行业落地,为我国加入PIC/S,更好地与国际接轨奠定基础。Objective:By analyzing the requirements of the Pharmaceutical Inspection Co-operation Scheme(PIC/S)Good Manufacturing Practice(GMP)Guidelines and Real-time Release Testing(RTRT)Appendix,this paper provides ideas and suggestions for the development and application of real-time release testing technology in China's pharmaceutical industry.Methods:This paper conducts in-depth research on the GMP guidelines and RTRT appendices of PIC/S,and discusses the feasibility of RTRT in China's pharmaceutical industry and its enlightenment to China's drug regulation by combining relevant RTRT regulations and literature at home and abroad.Results and Conclusion:China's drug regulatory authorities should benchmark the relevant technical requirements of PIC/S as soon as possible,combine the pilot experience of parameter release and the development characteristics of China's pharmaceutical industry,and issue RTRT guidelines that meet national conditions to ensure the implementation of RTRT in China's pharmaceutical industry and lay the foundation for China to join PIC/S and better integrate with international standards.

关 键 词：药品生产质量管理规范 药品检查合作计划 实时放行检测 药品监管 智能制造 监管科学 

分 类 号：R95[医药卫生—药学]