ISAR Publisher

International Scientific and Academic Research Publisher

Submit Manuscript

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


Author: Mr. Ashish Singh*
M.pharm in Pharmaceutical chemistry with honor’s.
Published Date: 2025-11-15
Keywords: Analytical Quality by Design, Product Lifecycle, Quality by Design, Method Validation, Risk Assessment, Continuous Improvement.
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.