A Modern Framework for Analytical Procedure Development and Lifecycle Management Based on ICH Q14 Principles

IF 6.7 1区化学 Q1 CHEMISTRY, ANALYTICAL Analytical Chemistry Pub Date : 2024-12-20 DOI:10.1021/acs.analchem.4c04521

Max Eberle, Jamie T. Wasylenko, Drazen Kostelac, Sarah Kiehna, Adam Schellinger, Zhaorui Zhang, Jason D. Ehrick

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Abstract

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.

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基于ICH Q14原则的分析程序开发和生命周期管理的现代框架

本文探讨了当前的分析方法验证实践，主要来源于国际人用药品技术要求协调委员会（ICH） Q2（R1）指南（2005），并提出了在制药工业中采用最新分析化学指南的策略（ICH Q14/Q2(R2), USP⟨1220⟩）。这些文件强调方法开发、鉴定和验证的生命周期方法，与未来提交档案结构的整体、基于风险的控制策略保持一致。ICH Q14中描述的增强方法的关键要素，包括分析目标概要（ATP）、知识管理、分析风险评估和绩效监控，被讨论并整合到一个明确的分析程序开发和生命周期管理的分析质量设计（AQbD）框架中。在利用基于风险的方法时，有必要在批准后灵活性的好处和实施附加要素所需的资源投资之间取得平衡。随着时间的推移，建议的策略应该简化分析开发，产生易于理解的分析方法，并简化生命周期管理。

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来源期刊

Analytical Chemistry 化学-分析化学

CiteScore

12.10

自引率

12.20%

发文量

1949

审稿时长

1.4 months

期刊介绍： Analytical Chemistry, a peer-reviewed research journal, focuses on disseminating new and original knowledge across all branches of analytical chemistry. Fundamental articles may explore general principles of chemical measurement science and need not directly address existing or potential analytical methodology. They can be entirely theoretical or report experimental results. Contributions may cover various phases of analytical operations, including sampling, bioanalysis, electrochemistry, mass spectrometry, microscale and nanoscale systems, environmental analysis, separations, spectroscopy, chemical reactions and selectivity, instrumentation, imaging, surface analysis, and data processing. Papers discussing known analytical methods should present a significant, original application of the method, a notable improvement, or results on an important analyte.