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

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 2025 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, 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.