Quality by Design (QbD) in pharmaceutical development: A comprehensive review

Abstract

Quality by Design (QBD) represents a transformative approach to pharmaceutical development, emphasizing a systematic and science-driven methodology to ensure consistent product quality. This article explores various facets of QBD, ranging from its foundational principles to challenges, opportunities, and future perspectives. The journey begins with an introduction to QBD, outlining its key concepts and objectives. The article then delves into the key principles of QBD, such as the establishment of a design space and the importance of risk assessment. Real-time Release Testing (RTRT) is discussed as a critical element in ensuring product quality and consistency. Case studies are presented, showcasing successful implementations of QBD in drug development and highlighting their impact on product quality and regulatory compliance. The regulatory landscape is examined, focusing on expectations and requirements related to QBD, as well as the integration of QBD concepts into regulatory submissions. Challenges and opportunities associated with QBD implementation are thoroughly explored, addressing industry-wide adoption challenges and strategies to overcome resistance to change. Continuous improvement emerges as a central theme, with a focus on its role in refining processes, learning from experiences, and fostering a culture of innovation. The article then looks towards the future, discussing the integration of advanced technologies, including analytical tools and Industry 4.0, and their implications for QBD. Global harmonization efforts are examined, emphasizing collaborative initiatives and their impact on aligning regulatory expectations globally.