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:
FAN Yiling
;
ZHU Ran
;
YANG Yan
;
JIANG Bo
;
SONG Minghui
;
WANG Jing
;
LI Qiongqiong
;
LI Gaomin
;
WANG Shujuan
;
SHAO Hong
;
MA Shihong
;
CAO Xiaoyun
;
HU Changqin
;
MA Shuangcheng,
;
YANG Meicheng
- Publication Type:Journal Article
- Keywords:
Chinese Pharmacopoeia;
microbiology;
lifecycle management;
process control
- From:
Drug Standards of China
2025;26(1):093-098
- 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 management system, and novel tools and methods with Chinese characteristics.
Results: The ChP 2025 edition demonstrates three prominent features in microbiological-related standards: enhanced international harmonization, introduced emerging molecular biological technologies, and established a risk-based microbiological quality control system.
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.
- Full text:20250311142934498820250213.pdf
