Eberle Max, Wasylenko Jamie T, Kostelac Drazen, Kiehna Sarah, Schellinger Adam, Zhang Zhaorui, Ehrick Jason D
AbbVie Deutschland GmbH & Co. KG, 67061 Ludwigshafen am Rhein, Germany.
AbbVie, Inc., North Chicago, Illinois 60064, United States.
Anal Chem. 2025 Jan 14;97(1):12-21. doi: 10.1021/acs.analchem.4c04521. Epub 2024 Dec 20.
This paper explores the current analytical method validation practices, mainly derived from the International Council for Harmonization of Technical Requirements for Pharmaceuticals for Human Use (ICH) Q2(R1) guidelines (2005) and presents a strategy for adopting the latest guidelines for analytical chemistry in the pharmaceutical industry (ICH Q14/Q2(R2), USP ⟨1220⟩). These documents emphasize a lifecycle approach to method development, qualification, and validation, aligning with the holistic, risk-based control strategy central to future submission dossier structures. Key elements of the enhanced approach described in ICH Q14, including Analytical Target Profile (ATP), Knowledge Management, Analytical Risk Assessment, and Performance Monitoring, are discussed and integrated into a clear Analytical Quality by Design (AQbD) framework for analytical procedure development and lifecycle management. When leveraging a risk-based approach, it is necessary to balance between the benefits of post-approval flexibility and the resource investments required for implementation of the additional elements. Over time, the proposed strategy should streamline analytical development, result in well-understood analytical methods, and simplify lifecycle management.
本文探讨了当前主要源自人用药品注册技术要求国际协调理事会（ICH）Q2(R1)指南（2005年）的分析方法验证实践，并提出了在制药行业采用最新分析化学指南（ICH Q14/Q2(R2)、美国药典⟨1220⟩）的策略。这些文件强调了方法开发、确认和验证的生命周期方法，与未来申报资料结构核心的整体、基于风险的控制策略相一致。讨论了ICH Q14中所述强化方法的关键要素，包括分析目标概况（ATP）、知识管理、分析风险评估和性能监测，并将其整合到一个清晰的用于分析程序开发和生命周期管理的设计质量分析（AQbD）框架中。在采用基于风险的方法时，有必要在批准后灵活性的益处与实施附加要素所需的资源投入之间取得平衡。随着时间的推移，所提出的策略应简化分析开发，产生易于理解的分析方法，并简化生命周期管理。
