目的 为业内人员更好的理解2020年版《中国药典》四部微生物控制体系提供帮助。方法 笔者介绍2020年版《中国药典》四部微生物控制体系的增修订概况和下一步工作展望。结果与结论 本版药典微生物控制体系在标准形成机制上更加科学,与ICH指导原则更加协调,与国际标准全面接轨,进一步强化了药品质量全过程控制要求,更加关注中药安全性控制,以期更好的提升药品质量、保障用药安全和服务药品监管。

OBJECTIVE To provide help for better understanding of the standards system for pharmaceutical microbial control of the Chinese Pharmacopoeia (Ch.P) 2020 Edition Volume Ⅳ. METHODS This article introduces the revision of the standards system for pharmaceutical microbial control of the Ch.P 2020 Edition Volume Ⅳ and the prospect of the next work. RESULTS AND CONCLUSION The microbiological control system is more scientific in the standard formation mechanism, more coordinated with ICH guideline and fully integrated with advanced international standards. It further strengthens the requirements for the whole process control of drug quality, pays more attention to the safety control of traditional Chinese medicine, and aims to improve drug quality, guarantee drug safety, and service drug supervision.