Implementation of Analytical Quality by Design (AQbD) in Analytical Method Development and Validation: Current Trends and Regulatory Perspectives Under ICH Q14 and ICH Q2(R2)

Analytical Quality by Design (AQbD) has evolved as a contemporary, science- and risk-based method to developing and validating analytical techniques in the pharmaceutical industry. This review seeks to offer a full overview of AQbD principles and their application to the recently adopted ICH Q14 and ICH Q2(R2) guidelines. A thorough literature search was undertaken with peer-reviewed articles, regulatory guidelines, and open-access resources such as PubMed, Google Scholar, ScienceDirect, and official ICH publications. The study covers essential AQbD features such as the Analytical Target Profile (ATP), risk assessment, Design of Experiments (DoE), Method Operable Design Region (MODR), lifecycle management, and chromatographic, dissolution, and spectroscopic applications. Furthermore, emerging concepts such as Green Analytical Chemistry, White Analytical Chemistry, Artificial Intelligence, and Machine Learning are discussed. The findings show that AQbD increases analytical robustness, regulatory flexibility, and method lifecycle management, and that future analytical research will be more driven by AI-assisted and sustainable methodologies.