摘要
随着科学技术的进步、生产设备的更新以及质量控制理念和管理方式的改变等,生产工艺变更对于中药质量控制具有特别重要的意义,是中药制剂质量提升的重要途径。制订符合中药变更特点和规律,科学、合理、可行的中药变更研究技术指导原则,是引导中药制剂高质量发展的重要手段。本文通过回顾总结中药工艺变更管理及技术要求的历史与现状,介绍《已上市中药药学变更研究技术指导原则(试行)》制订情况、主要特点,以期对业界同仁有所帮助。
With the advancement of science and technology,the upgrade of production equipment,and changes in quality control concepts and management methods,changes in production process are particularly important to the quality control of traditional Chinese medicine(TCM),and are important ways to improve the quality of TCM preparations.It is,therefore,crucial to formulate scientific,reasonable and feasible technical guidance for the study of TCM changes,in line with the characteristics and patterns of TCM changes.The guidance will be an important means of improving TCM preparations.This article reviews and summarizes the history and current situation of management and technical requirements for TCM changes,and introduces the formulation process and characteristics of the Guidance on Post-Market Changes in CMC of Traditional Chinese Medicines(Interim),hoping to provide support for industry.
作者
赵巍
阳长明
周思源
李计萍
赵晓霞
ZHAO Wei;YANG Chang-ming;ZHOU Si-yuan;LI Ji-ping;ZHAO Xiao-xia(Center for Drug Evaluation,National Medical Products Administration)
出处
《中国食品药品监管》
2021年第9期100-105,共6页
China Food & Drug Administration Magazine
关键词
已上市中药药学变更研究技术指导原则(试行)
工艺变更研究
变更管理
技术要求
Guidance on Post-Market Changes in CMC of Traditional Chinese Medicines(Interim)
research on manufacturing process change
change management
technical requirements
