Quality by design in pharmaceutical analysis: Essential but underutilized

Abstract

Quality by Design (QbD) has emerged as a transformative framework in pharmaceutical analysis, offering a systematic and science-driven approach to ensure the quality and reliability of analytical methods. Rooted in the principles of quality management, QbD emphasizes understanding and controlling variability through tools, such as Quality Target Product Profile, Critical Quality Attributes, and Design of Experiments. Despite its advantages in enhancing method robustness, regulatory compliance, and cost efficiency, the adoption of QbD in pharmaceutical analysis remains limited due to challenges such as lack of expertise, high implementation costs, and resistance to change. This review explores the principles and applications of QbD in analytical method development, highlighting its role in optimizing chromatographic, dissolution, and spectroscopy techniques. In addition, it addresses the barriers to QbD implementation and identifies opportunities for advancement through education, technological innovations, and regulatory support, underscoring its potential to revolutionize quality assurance practices in the pharmaceutical industry.