化学原料药杂质研究过程中的风险管理
Risk Management in API Impurity Research
陈烨 1吴岩2
作者信息
- 1. 南通大学药学院,江苏南通 226001
- 2. 江苏威奇达药业有限公司,江苏南通 226133
- 折叠
摘要
以江苏某制药公司为实证研究对象,对某化学原料药杂质研究过程中使用风险评估方法,结果显示,在药品杂质研究过程中充分应用风险管理的理念,使用合适的风险管理工具,能更科学、全面地对药品质量进行控制.
Abstract
Taking a pharmaceutical company in Jiangsu as the empirical research object,the risk assessment method was used in a certain API's impurity research process.The results showed that fully applying the concept of risk management and using appropriate risk management tools in the drug impurity research process can more scientifically and comprehensively control drug quality.
关键词
杂质研究/风险管理/风险管理工具Key words
impurity research/risk management/risk management tools引用本文复制引用
出版年
2024
NETL
NSTL
万方数据