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.
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)
出处
《中国药事》
CAS
2023年第5期513-519,共7页
Chinese Pharmaceutical Affairs
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
Good Manufacturing Practice
Pharmaceutical Inspection Co-operation Scheme
real time release testing
drugs regulation
smart manufacturing
regulatory science