摘要
目的为规范化学原料药生产工艺变更研究提供参考。方法结合审评工作中的具体案例,对目前原料药生产工艺变更申请中常见的、有一定代表性的问题进行分析。结果与结论原料药生产工艺变更可能引发产品质量特征的变化,需通过对变更前后产品的结构、质量、稳定性等方面进行全面对比研究,来评估变更是否对药品的安全性、有效性和质量可控性产生负面影响。
Objective To provide reference to manufacturing process variation research for approved chemical drug substances.Methods The common problems encountered in the manufacturing process variation research for approved chemical drug substances were analyzed,and the cases in technical review were studied.Results and Conclusion Changes to the manufacturing process may result in alteration of drug quality characteristic.Comparison study on structure,quality and stability prior and after changes should be performed to overall evaluate the impact on safety,efficacy and quality of the final drug product.
出处
《中国药事》
CAS
2011年第1期47-50,共4页
Chinese Pharmaceutical Affairs
关键词
原料药
生产工艺
变更研究
drug substance
manufacturing process
variation research
