Vol. 7, Issue 2, Part H (2025)

Quality by Design (QbD) has emerged as a modern and systematic framework for developing pharmaceutical products with robust and reproducible quality. It represents a key component of contemporary pharmaceutical quality strategies, emphasizing the proactive design of processes rather than relying solely on end-product testing. Although QbD offers an effective pathway for embedding quality throughout product development, its adoption remains challenging for industries where manufacturing practices are traditionally rigid despite natural variations in processes and raw materials. This review highlights the fundamental principles of QbD, outlining its major components, including identification of critical process parameters and critical quality attributes across different stages of production. The benefits, opportunities, and sequential steps involved in implementing QbD in pharmaceutical development are discussed in detail. Ultimately, the goal of pharmaceutical development is to create products and processes capable of consistently achieving the desired therapeutic performance. As quality must be incorporated during design-not inspected afterward-this paper explains how QbD can streamline development and support timely delivery of high-quality pharmaceutical products.