The paper discusses the concept of Pharmaceutical Quality by Design (QbD) and its application in ensuring pharmaceutical quality, particularly for solid oral dosage forms of small molecules. The authors highlight that QbD is a systemic approach to pharmaceutical development, emphasizing the importance of designing and developing formulations and manufacturing processes to ensure predefined product quality. Key elements of QbD include defining target product quality profiles, designing processes, identifying critical quality attributes and process parameters, and controlling manufacturing processes to produce consistent quality over time. The paper contrasts QbD with traditional quality by testing (QbT) methods, which rely heavily on extensive testing and fixed manufacturing processes, leading to inflexibility and resource-intensive reviews. The introduction of QbD is seen as a way to transform the chemistry, manufacturing, and controls (CMC) review of abbreviated new drug applications (ANDAs) into a more science-based and flexible quality assessment system. The benefits of QbD include improved product quality, facilitated continuous improvement, enhanced CMC review quality, and reduced review time.The paper discusses the concept of Pharmaceutical Quality by Design (QbD) and its application in ensuring pharmaceutical quality, particularly for solid oral dosage forms of small molecules. The authors highlight that QbD is a systemic approach to pharmaceutical development, emphasizing the importance of designing and developing formulations and manufacturing processes to ensure predefined product quality. Key elements of QbD include defining target product quality profiles, designing processes, identifying critical quality attributes and process parameters, and controlling manufacturing processes to produce consistent quality over time. The paper contrasts QbD with traditional quality by testing (QbT) methods, which rely heavily on extensive testing and fixed manufacturing processes, leading to inflexibility and resource-intensive reviews. The introduction of QbD is seen as a way to transform the chemistry, manufacturing, and controls (CMC) review of abbreviated new drug applications (ANDAs) into a more science-based and flexible quality assessment system. The benefits of QbD include improved product quality, facilitated continuous improvement, enhanced CMC review quality, and reduced review time.