Considerations For Strategic Partnering With CRO/CMOs: Incorporating QbD Early In Product Development Is Key To Success

By Ron Connolly, Vaishali Ketkar, Amit Shah, and Veerarajendra (Raj) Yadwad, Frontage Laboratories

The pharmaceutical industry is continually looking to accelerate and streamline the product development process to bring new products to the market efficiently. For the last few years the U.S. and EU regulatory communities have worked together to develop guidelines that encourage implementation of the principles of Quality by Design (QbD) in the drug development process. The QbD initiative is a science- and risk-based approach to pharmaceutical process development and manufacturing. Implementing QbD principles earlier in the drug development program enhances the development team’s understanding of critical control requirements and encourages collaboration between product/process development, quality, and manufacturing personnel.