Quality by Design (QbD) in pharmaceutical development: A comprehensive review
1 Department of Pharmacy, Shraddha Institute of Pharmacy, Washim, Maharashtra, India.
2 Department of Quality Assurance, Shraddha Institute of Pharmacy, Washim, Maharashtra, India.
3 Department of Pharmacology, Shraddha Institute of Pharmacy, Washim, Maharashtra, India.
Review Article
GSC Biological and Pharmaceutical Sciences, 2024, 26(01), 328–340.
Article DOI: 10.30574/gscbps.2024.26.1.0019
Publication history:
Received on 10 December 2023; revised on 20 January 2024; accepted on 22 January 2024
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.
Keywords:
Quality by Design (QBD) Pharmaceutical Development; International Conference on Harmonization (ICH); Risk Management; Critical Quality Attributes (CQAs); Critical Process Parameters (CPPs); Design Space; Real-time Release Testing (RTRT); Regulatory Compliance; Continuous Improvement; Empirical Methods; Predictability; Consistency; Case Studies; Industry 4.0; Advanced Technologies; Global Harmonization; Paradigm Shift; Patient Safety
Full text article in PDF:
Copyright information:
Copyright © 2024 Author(s) retain the copyright of this article. This article is published under the terms of the Creative Commons Attribution Liscense 4.0
