实施ICH Q14的实用方法:在毛细管电泳法开发中设计分析质量的工具
Ewoud van Tricht1, Cari E Sänger-van de Griend1,2
1Kantisto B.V., Haaksbergen, the Netherlands.
Electrophoresis
|March 18, 2025
概括
本研究提出了一种实用,用户友好的方法来实施分析质量设计 (AQbD) 原则和分析方法开发的ICH Q14指南. 它提供了准备好使用的工具,以简化工艺设计,优化,验证和工业环境中的实施.
科学领域:
- 制药科学 制药科学
- 分析化学 分析化学
- 监管科学 监管科学
背景情况:
- ICH Q14指南促进了设计时的分析质量 (AQbD),以开发强大的分析方法.
- 由于缺乏全面的实践实例和培训资源,实施方面的挑战仍然存在.
- 现有的研究往往侧重于孤立的AQbD方面,留下了整体生命周期支持的差距.
研究的目的:
- 为实施ICH Q14和AQbD原则提供一种新的,用户友好的方法.
- 为整个分析生命周期提供实用,准备实施的工具.
- 在分析方法开发中弥合AQbD理论和现实世界的应用之间的差距.
主要方法:
- 开发一个逐步方法,将AQbD集成到分析工作流程中.
- 为方法设计,优化,验证和实施创建用户友好的工具.
- 在各种工业环境中测试该方法,以确保可靠性和有效性.
主要成果:
- 一种结构化,实用的方法简化了ICH Q14和AQbD的实施.
- 在各种工业应用中证明了可靠性和有效性.
- 促进将AQbD原则纳入常规分析工作流程.
结论:
- 提出的方法有效地解决了实施ICH Q14和AQbD的实际挑战.
- 它提供了有价值的工具和最佳实践,用于在分析方法开发中无地采用AQbD.
- 这项工作支持在整个产品生命周期中更广泛地采用稳健可靠的分析方法.
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