Review on - Analytical Quality by Design (AQbD) A Novel Approach for Method Development

Analytical Quality by Design (AQbD) is a systematic, science- and risk-based approach for analytical method development that ensures robustness, reliability, and lifecycle management. Unlike traditional trial-and-error methods, AQbD focuses on predefined objectives, comprehensive method understanding, and statistical evaluation of method variables. Regulatory authorities encourage AQbD implementation to enhance method performance and flexibility. This review describes the AQbD framework, including Analytical Target Profile (ATP), Critical Quality Attributes (CQAs), risk assessment, Design of Experiments (DoE), Method Operable Design Region (MODR), control strategy, and lifecycle management, with emphasis on pharmaceutical analytical applications