Interpretation of"Guideline 9212 risk assessment and control of objectionable microorganisms for non-sterile products"in Chinese Pharmacopoeia 2025 Edition
10.19778/j.chp.2025.05.002
- VernacularTitle:2025年版《中国药典》9212非无菌产品不可接受微生物风险评估与控制指导原则解读
- Author:
Minghui SONG
1
;
Ning ZHANG
;
Qiongqiong LI
;
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:
non-sterile products;
objectionable microorganisms;
risk assessment;
risk control;
interpretation of standards
- From:
Drug Standards of China
2025;26(5):455-461
- CountryChina
- Language:Chinese
-
Abstract:
The microbial limit standards in the Chinese Pharmacopoeia 2020 edition primarily focus on total aerobic microbial count and specified objectionable microorganisms,which are insufficient for comprehensively assessing the potential risks posed by microbial contamination to drug efficacy and patient safety.With the increasing com-plexity of rising regulatory requirements,there is an urgent need to establish a scientific and systematic microbial risk assessment and control framework.In response,the Chinese Pharmacopoeia 2025 edition,introduces a new general guideline 9212 Risk Assessment and Control of Unacceptable Microorganisms for Non-sterile Products.This chapter systematically constructs a framework for the identification and control of risks associated with unacceptable microorganisms,filling a gap in the relevant field within international pharmacopoeias.This article systematically elaborates on its key elements based on its core framework and content.It covers the development background,core concepts,testing and identification strategies,evaluation of risk characterization factors,formulation of risk control measures,and implementation pathways.The aim is to provide pharmaceutical enterprises and regulatory agencies with systematic and clear practical guidance.
