Abstract：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.
朱冉, 许华玉, 宋宗华. 2020年版《中国药典》四部微生物控制体系的增修订概况及展望[J]. 中国药学杂志, 2020, 55(19): 1564-1568.
ZHU Ran, XU Hua-yu, SONG Zong-hua. Review on Revision of the Standards System for Pharmaceutical Microbial Control of the Chinese Pharmacopoeia 2020 Edition Volume Ⅳ. Chinese Pharmaceutical Journal, 2020, 55(19): 1564-1568.