Tricht Ewoud van, Sänger-van de Griend Cari E
Kantisto B.V., Haaksbergen, the Netherlands.
Faculty of Pharmacy, Department of Medicinal Chemistry, Division of Analytical Pharmaceutical Chemistry, Uppsala University, Uppsala, Sweden.
Electrophoresis. 2025 Mar 18. doi: 10.1002/elps.8110.
The ICH Q14 guideline introduces a structured framework for analytical method development based on Analytical Quality by Design (AQbD) principles, aiming to ensure robust, reliable, and fit-for-purpose methods throughout the product lifecycle. However, implementing ICH Q14 remains challenging due to the lack of complete examples and training resources, making it difficult for organizations to translate theory into practice. Although previous studies have applied AQbD to capillary electrophoresis method development, many have focused only on specific aspects such as the design of experiments (DoEs) or analytical target profile (ATP), leaving a gap in providing comprehensive, practical tools for the entire analytical lifecycle. This manuscript presents a novel, user-friendly approach to implementing ICH Q14 and AQbD, offering ready-to-implement tools and methodologies that simplify the process of method design, optimization, validation, and implementation. Through a stepwise process, the approach provides practical solutions for integrating AQbD principles into everyday workflows, bridging the gap between theoretical concepts and real-world applications. The approach has been thoroughly tested in diverse industrial settings, demonstrating its reliability and effectiveness. This work aims to facilitate the adoption of AQbD in analytical method development by providing structured tools, lessons learned, and best practices that align with ICH Q14 guidelines.
国际人用药品注册技术协调会（ICH）Q14指南引入了一个基于设计分析质量（AQbD）原则的分析方法开发结构化框架，旨在确保在产品整个生命周期内方法的稳健性、可靠性和适用性。然而，由于缺乏完整的示例和培训资源，实施ICH Q14仍然具有挑战性，这使得各组织难以将理论转化为实践。尽管先前的研究已将AQbD应用于毛细管电泳方法开发，但许多研究仅关注特定方面，如实验设计（DoE）或分析目标概况（ATP），在为整个分析生命周期提供全面实用工具方面存在空白。本手稿提出了一种新颖、用户友好的实施ICH Q14和AQbD的方法，提供了易于实施的工具和方法，简化了方法设计、优化、验证和实施过程。通过逐步过程，该方法为将AQbD原则融入日常工作流程提供了实际解决方案，弥合了理论概念与实际应用之间的差距。该方法已在不同工业环境中进行了全面测试，证明了其可靠性和有效性。这项工作旨在通过提供与ICH Q14指南一致的结构化工具、经验教训和最佳实践，促进AQbD在分析方法开发中的应用。
