Copyright © 2026 Authors retain the copyright of this article. This article is an open access article distributed under the Creative Commons Attribution License which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly cited.

@article{205438,
        author = {Manasvi Sonavane and Dr. Sunila A. Patil},
        title = {Quality By Design (QbD): A Modern Approach To Enhancing Pharmaceutical Product Quality And Regulatory Compliance},
        journal = {International Journal of Innovative Research in Technology},
        year = {2026},
        volume = {13},
        number = {1},
        pages = {8588-8591},
        issn = {2349-6002},
        url = {https://ijirt.org/article?manuscript=205438},
        abstract = {The pharmaceutical industry is progressively adopting Quality by Design (QbD) as a systematic approach to development that emphasizes designing quality into products from the outset. This review explores the foundational principles, regulatory frameworks, and practical applications of QbD in pharmaceutical formulation and analytical method development. Key components such as Quality Target Product Profile (QTPP), Critical Quality Attributes (CQAs) and Process Analytical Technology (PAT) are discussed. The review also highlights the role of Analytical QbD (AQbD) and examines real-world case studies that demonstrate the benefits of QbD, including enhanced product understanding, reduced variability, and improved regulatory flexibility. Challenges and future perspectives are addressed, underscoring the evolving integration of QbD with digital technologies and lifecycle management.},
        keywords = {CQAs), Pharmaceutical Development, Risk Management, Lifecycle Management.},
        month = {June},
        }