A Comprehensive Review on Analytical Quality by Design (AQbD) in Product Development: A Scientific and Lifecycle Approach

Abstract: Analytical Quality by Design (AQbD) is a modern scientific approach that ensures analytical methods are developed, validated, and maintained using a systematic, risk-based framework throughout the product lifecycle. AQbD emphasizes product and process understanding, design of experiments (DoE), and continuous improvement, ensuring quality is built into analytical procedures from the beginning. This review highlights the significance of AQbD in pharmaceutical product development, its regulatory foundation, and its role in enhancing the analytical lifecycle, scientific integrity, and overall product quality.