ROLE OF QUALITY BY DESIGN (QBD) IN ENHANCING THE ROBUSTNESS OF SOLID ORAL DOSAGE FORMS

Quality by Design (QbD) has revolutionized pharmaceutical product development by enabling a systematic approach to design and control processes that enhance product robustness. This review highlights the role of QbD principles, such as Critical Quality Attributes (CQAs), Critical Process Parameters (CPPs), and Design of Experiments (DoE), in improving the development and manufacturing of solid oral dosage forms. Incorporating QbD reduces batch failures, ensures consistent drug quality, and supports regulatory compliance. The implementation of Process Analytical Technology (PAT) and continuous lifecycle monitoring further contributes to the robustness of oral formulations. This study synthesizes current literature and case studies demonstrating how QbD fosters scalable, robust, and high-quality solid dosage forms.