分析方法持续确认指标和评估方式的探讨
Discussion the ongoing verification indicators and evaluation approachs of analytical procedure
李娜 1杜颖 2耿颖 2靳朝晖 1曲晓蒙 1聂晓齐 1谭德讲2
作者信息
- 1. 北京民海生物科技有限公司,北京 102609
- 2. 中国食品药品检定研究院国家药品监督管理局化学药品质量研究与评价重点实验室,北京 102629
- 折叠
摘要
分析方法性能持续确认是确保方法在完成验证后持续满足其预期用途的过程.本文在前期研究的基础上,进一步探讨方法性能持续确认的指标(包括系统适用性指标和报告值等)和实施分析工具(控制图),并以示例演示方法性能持续确认的具体操作步骤.希望本文可以为药品领域,特别是企业和监管部门在方法确认的科学化、规范化方面提供新的思路.
Abstract
Ongoing procedure performance verification(OPPV)of an analytical procedure is the process of ensu-ring it continues to meet its intended use after completion of validation.On the basis of previous studies,this pa-per further discussed the indicators of ongoing procedure performance verification(including system suitability in-dicators and reported values,etc.)and the implementation of analysis tools(control charts),and demonstrated the specific operation steps of ongoing procedure performance verification with examples.It is hoped that this pa-per will provide new ideas for the accurate and standardized procedure verification in the pharmaceutical field,es-pecially in the enterprises and regulatory departments.
关键词
方法确认/方法性能持续确认/分析方法全生命周期/控制图/分析控制属性Key words
procedure verification/ongoing procedure performance verification/analytical procedure life-cycle/control chart/analytical control attributes引用本文复制引用
出版年
2024
NETL
NSTL
万方数据