摘要
本文分析了实施新修订药品生产质量管理规范过程中药品技术转让研究相关要求和需要重点关注的问题,对药品技术转让涉及的生产工艺、质量以及稳定性研究的重点内容进行了分析说明。
This article analyzed the correlated requirements on study of drug technology transfer in process of practicing new revised GMP and the problems of needing to focus. The production technology,quality and stability study of drug tech-nology transfer involved were analyzed and described.
出处
《药学研究》
CAS
2015年第4期240-241,共2页
Journal of Pharmaceutical Research
