Interpretation of"Guideline 9110 for microbial whole genome sequencing technology"in Chinese Pharmacopoeia 2025 Edition
10.19778/j.chp.2025.05.001
- VernacularTitle:2025年版《中国药典》新增9110微生物全基因组测序技术指导原则解读
- Author:
Minghui SONG
1
;
Xin DOU
;
Hong SHAO
;
Yiling FAN
;
Meicheng YANG
;
Shihong MA
;
Jun ZHANG
;
Changqin HU
Author Information
1. 上海市创新生物制品质量检验检测中心,生化药品生物制品微生物所,上海市食品药品检验研究院,上海 201203
- Publication Type:Journal Article
- Keywords:
whole genome sequencing;
pharmacopoeia standard;
microbial identification;
application guidance;
technical specifications
- From:
Drug Standards of China
2025;26(5):449-454
- CountryChina
- Language:Chinese
-
Abstract:
Whole Genome Sequencing(WGS)technology,leveraging its significant advantages in precise microbial identification and traceability analysis,has become a core tool in international pharmaceutical microbial quality control.The release and implementation of the Guideline 9110 for Microbial Whole Genome Sequencing Technology in the Chinese Pharmacopoeia 2025 Edition marks the official entry of China's pharmaceutical microbial quality con-trol into the genomic era.Guideline 9110 establishes universal technical specifications for the application of WGS technology in pharmaceutical microbial quality control,covering laboratory general requirements,key technical parameters,technical workflow,major factors affecting sequencing results,method validation,and application guidance.This article focuses on the background of the standard's development and its technical rationale,provi-ding a systematic interpretation of key technical indicators,the scope of application,and essential points for techni-cal implementation.It aims to offer theoretical guidance and practical references for the industry in applying WGS technology.
