摘要
根据ICH Q3C要求,参考国际主流药典转化实施过程,结合原料、辅料和生产工艺开展风险评估,对化学药制剂中可能存在的残留溶剂开展风险研判研究,探讨《中华人民共和国药典》二部化学药品残留溶剂控制与ICH Q3C相协调的研究思路,以期对ICH Q3C在《中华人民共和国药典》二部品种的整体协调提供借鉴,也为监管部门指导生产企业开展残留溶剂风险评估提供技术参考。
In alignment with ICH Q3C guidelines and with reference to the implementation requirements of major international pharmacopoeias,a risk assessment was performed based on the evaluation of raw materials,excipients,and production processes to investigate potential residual solvents in pharmaceutical products.This study explores a harmonization strategy for harmonizing the control of residual solvents in chemical drugs under the Chinese Pharmacopoeia(VolumeⅡ)with ICH Q3C guidelines.The proposed approach aims to serve as a reference for the systematic harmonization of ICH Q3C within the monographs of ChP VolumeⅡand to provide technical guidance for regulatory authorities in advising manufacturers on conducting risk assessments for residual solvents.
作者
黄朝瑜
严菲
姚枝玉
邵方娴
李睿
王玉
HUANG Chao-yu;YAN Fei;YAO Zhi-yu;SHAO Fang-xiang;LI Rui;WANG Yu(Jiangsu Institute for Drug Control,Nanjing 210019,China;Key Laboratory of Chemical Impurity Spectrometry,National Medical Products Administration,Nanjing 210019,China)
出处
《中国新药杂志》
北大核心
2026年第1期1-5,共5页
Chinese Journal of New Drugs
基金
国家药典委员会课题:ICH Q3C在中国药典二部品种转化研究-残留溶剂测定法(2024H02)。
关键词
化学药品
残留溶剂
ICH
控制策略
chemical drug
residual solvents
ICH
control strategy
