Interpretation of"Guideline 9213 for validation,verification,and transfer of microbiological analytical methods"in Chinese Pharmacopoeia 2025 Edition
10.19778/j.chp.2025.05.003
- VernacularTitle:对2025年版《中国药典》新增9213药品微生物分析方法验证、确认及转移指导原则的解读
- Author:
Yan YANG
1
;
Hong SHAO
;
Shujuan WANG
;
Rong FU
;
Qian YANG
;
Junhao CHEN
;
Zhen SHEN
;
Chunyan AN
;
Yiling FAN
;
Meicheng YANG
;
Jun ZHANG
;
Changqin HU
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,上海市药品检验研究院,上海 201203
- Publication Type:Journal Article
- Keywords:
microbiological analytical method;
validation;
verification;
transfer;
suitability testing
- From:
Drug Standards of China
2025;26(5):462-467
- CountryChina
- Language:Chinese
-
Abstract:
The Chinese Pharmacopoeia 2025 Edition added the 9213 Guideline for validation,verification,and transfer of microbiological analytical methods.Based on the characteristics of pharmaceutical microbiological analyt-ical methods and practical applications,it specified definitions of relevant terms and application scenarios,estab-lished technical indicators and acceptance criteria for methodological evaluation,and introduced key statistical tools and evaluation principles.This article systematically elaborates on the drafting background and process of the Guideline,and interprets its key content,aiming to offer theoretical guidance and practical reference for relevant practitioners in applying this guideline.This guideline strengthens the foundation of pharmaceutical microbial analytical methods in China and enhances the scientificity and accuracy of the pharmaceutical microbial standards system.
