《中国药典》2025年版微生物质控体系的主要变化与展望

The Key Changes of Microbial Control System in Chinese Pharmacopoeia 2025 Edition and the Trend

关键词:  中国药典2020 年版  药品微生物标准  药品微生物控制  标准修订

Key words:  Chinese Pharmacopoeia 2025 Edition  specification on pharmaceutical microbial control  pharmaceutical microbial control  specification revision

摘要:

药品微生物控制体系伴随着时代的变化而发展。本文对中国药典2025 年版增修订工作的重点进行了解读,其关键点可概括为：通过与ICH Q4B的协调实现与国际标准完全接轨；推动风险管理理念的实施；结合落实药品上市许可持有人(MAH)的主体责任,全面提高产品的质量控制水平。通过对中国药典近年来在微生物控制体系建设中的主要关注点的阐述,明确了未来的工作将围绕着推进生产过程控制理念的实施,提升企业药品微生物实验室的能力与管理水平,促使企业成为微生物污染控制的主体而开展。

Abstract:

ABSTRACT: The pharmaceutical microbial contamination control system has evolved along with the changes of the times. In this paper, the key aspects of addition and revision of Chinese Pharmacopoeia 2020 Edition is elucidated，which can be summarized as: achieving comprehensive alignment with international standards through coordination with ICH Q4B; promoting the implementation of the risk management concept, combined with the implementation of the main responsibility of the drug marketing authorization holder (MAH), to comprehensively improve the quality control level of products. Through the elaboration on the main concerns of the Chinese Pharmacopoeia in the construction of the microbial control system in recent years, it is clarified that in the future, efforts will be further focused on promoting the implementation of the production process control concepts, enhancing the ability and management level of the manufacture's microbial laboratory, and enabling manufactures to become the main body in microbial contamination control.