A Practical Approach to Implementing ICH Q14: Tools for Analytical Quality by Design in Capillary Electrophoresis Method Development.

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.