Changes and Trends in the microbiological-related standards in the Chinese Pharmacopoeia 2025 Edition
10.19778/j.chp.2025.01.013
- VernacularTitle:2025年版《中国药典》微生物标准的变化与发展趋势
- Author:
Yiling FAN
1
;
Ran ZHU
;
Yan YANG
;
Bo JIANG
;
Minghui SONG
;
Jing WANG
;
Qiongqiong LI
;
Gaomin LI
;
Shujuan WANG
;
Hong SHAO
;
Shihong MA
;
Xiaoyun CAO
;
Changqin HU
;
Shuangcheng MA
;
Meicheng YANG
;
Jun ZHANG
Author Information
1. 国家药监局药品微生物检测技术重点实验室,上海市创新生物制品质量检验检测中心,上海市食品药品检验研究院,上海 201203;中国医药工业研究总院,上海 201203
- Publication Type:Journal Article
- Keywords:
Chinese Pharmacopoeia;
microbiology;
lifecycle management;
process control
- From:
Drug Standards of China
2025;26(1):93-98
- CountryChina
- Language:Chinese
-
Abstract:
Objective:To systematically analyze the revisions content and technological development trends of microbiological standards in the Chinese Pharmacopoeia(ChP)2025 Edition,and explore its novel requirements in risk-based pharmaceutical product lifecycle management.Methods:A comprehensive review was conducted on 26 microbiological-related standards to summarize the revision directions and scientific implications from perspectives including the revision overview,international harmonization of microbiological standards,risk-based quality man-agement system,and novel tools and methods with Chinese characteristics.Results:The ChP 2025 edition demon-strates three prominent features in microbiological-related standards:enhanced international harmonization,intro-duced emerging molecular biological technologies,and established a risk-based microbiological quality control sys-tem.Conclusion:The new edition of the Pharmacopoeia has systematically constructed a microbiological standard system,which significantly improves the scientificity,standardization and applicability of the standards,providing a crucial support for advancing the microbiological quality control in pharmaceutical industries of China.
