Risk Assessment in Quality by Design (QbD) Approach for Oral Solid Dosage Forms

Quality by Design (QbD) is a systematic, science- and risk-based approach to pharmaceutical development that emphasizes designing quality into products rather than relying solely on end-product testing. Risk assessment is a fundamental component of the QbD framework and plays a decisive role in identifying, analyzing, and controlling sources of variability that may impact product quality. Oral solid dosage forms (OSDFs), such as tablets and capsules, involve complex interactions between formulation components and manufacturing processes, making them particularly sensitive to material and process-related risks. This review comprehensively discusses the application of risk assessment within the QbD framework for OSDFs, including regulatory expectations, quality risk management principles, critical quality attributes, commonly used risk assessment tools, formulation and process risks, control strategies, and lifecycle management. The integration of structured risk assessment with QbD enhances process robustness, regulatory flexibility, and patient safety.