157 - The Role of Quality by Design (QbD) in Pharmaceutical Development and Manufacturing (S11E7)

10 min • 24 maj 2025

This episode focuses on the Quality by Design (QbD) approach and its implementation in the pharmaceutical industry to enhance product quality and process understanding. The core principles of QbD are detailed, emphasizing the importance of predefined objectives, deep understanding of the product and process, and control based on sound science and risk management. It also discusses how the use of Design of Experiments (DoE) is crucial for gaining this understanding and mapping out the relationships between process parameters and critical quality attributes (CQAs).

The conversation turns to a real-world example, Torcetrapib, to illustrate how DoE helped define the Design Space and uncover hidden complexities. The alignment of QbD with regulatory expectations is explored, highlighting how it demonstrates a deep level of understanding and control, ultimately reducing risk and building confidence. Key takeaways include the shift towards a proactive, science-driven approach to ensuring pharmaceutical quality and a focus on process understanding to enable effective control over critical quality attributes. It also delves into the process of developing drug.