摘要
目的为《中华人民共和国药典》(以下简称《中国药典》)中的过程分析技术(process analytical technology,PAT)相关通则的制定和修订提供参考。方法通过梳理各国药典和有关文献,介绍并总结各国药典中PAT相关通则的概况。结果近年来,各国药典陆续修订了与PAT相关的通则,介绍PAT的应用和益处,为工业界和监管机构提供了技术支撑,共同促进PAT在技术、工艺和监管方面的进步。结论建议《中国药典》借鉴各国药典的成果和经验,在过程分析仪器技术、物料物理属性相关的分析方法标准、用于数据分析的化学计量学和多变量统计过程控制等方面开展《中国药典》相关通则的制定和修订,不断完善我国在PAT领域的监管制度,促进PAT在我国制药行业中的应用。
Objective To provide a reference for the development and revision of general chapters of process analytical technology(PAT)in Chinese Pharmacopoeia.Methods By combing the pharmacopoeias and literatures,the general chapters of PAT in the pharmacopoeias were introduced.Results In recent years,the general chapters of PAT were developed and revised successively in the pharmacopoeias to introduce the application and benefits of PAT,provide technical support for industry and regulators,and promote the progress of PAT in technology,process,and regulations.Conclusion It is suggested that the Chinese Pharmacopoeia should learn from the achievements and experience of other pharmacopoeias,and develop and revise the general chapters of instrument analytical methods,testing methods of physical characteristics of materials,chemometrics and multivariate statistical process control,constantly improve the regulatory framework in the field of PAT in China,and promote the application of PAT in Chinese pharmaceutical industry.
作者
徐昕怡
洪小栩
XU Xinyi;HONG Xiaoxu(Chinese Pharmacopoeia Commission,Beijing 100061,China)
出处
《西北药学杂志》
CAS
2023年第6期250-259,共10页
Northwest Pharmaceutical Journal
基金
科技部国家科技基础资源调查专项(编号:2018FY00803)
国家药典委员会国家药品标准制修订研究课题(编号:2022Y12)。
关键词
过程分析技术(PAT)
药典
通则
process analytical technology(PAT)
pharmacopoeia
general chapter