Interpretation of"Guidelines 9211 for application of water activity in the microbial control of nonsterile pharmaceutical drugs"in Chinese Pharmacopoeia 2025 Edition
10.19778/j.chp.2025.05.004
- VernacularTitle:对2025年版《中国药典》9211非无菌药品微生物控制中水分活度应用指导原则的解读
- Author:
Meng JIA
1
;
Hong MIN
1
;
Linyue LI
1
;
Yuhua XIE
1
;
Xiaoli YANG
1
Author Information
1. 陕西省食品药品检验研究院,国家药品监督管理局药品微生物检测技术重点实验室,西安 710065
- Publication Type:Journal Article
- Keywords:
water activity;
microbiological limit;
non-sterile drugs;
microbial control
- From:
Drug Standards of China
2025;26(5):468-472
- CountryChina
- Language:Chinese
-
Abstract:
The 2025 edition of the Chinese Pharmacopoeia Volume Ⅳ has added General Chapter 9211"Guidelines for the Application of Water Activity in Microbial Control of Non-sterile Pharmaceuticals".This guideline is rela-tively new in China's pharmaceutical industry,and it also serves as an important concept and measure to compre-hensively promote microbial process control of pharmaceuticals,conduct microbial quality risk management,and optimize microbial limit setting for non-sterile pharmaceuticals.This article elaborates and interprets the guidelines from four aspects:the background of establishing the guidelines,the necessity and significance of adding the guide-lines,the process of adding the guidelines,and the main framework and key content of the guidelines.It aims to guide enterprises to optimize formulations,formulate personalized microbial control strategies,and realize the trans-formation from terminal quality control to process control,so as to provide important tools and theoretical guidance for microbial quality risk management.
