QbD: A Framework For Improved Decision Making Throughout Drug Development

By Amy Lachapelle, QBD Strategies, LLC

By Amy L. Lachapelle, QBD Strategies, LLC

A frequent complaint of process engineers tasked with implementing quality by design (QbD) is the lack of information provided by their upstream development teams. For QbD to be  implemented efficiently, at least 80% of the knowledge needed for process development must be generated in the R&D phase and transferred downstream. When downstream teams are provided with sufficient information, the time and effort required to optimize and control the process is significantly reduced, resulting in both cost savings and quicker time to market.    

According to the 2009 FDA report  Understanding Challenges to Quality by Design, “taking advantage of a growing knowledge base during the product development process can lead to $4-$5 billion dollars in savings” for the biopharmaceutical industry. Implementation of QbD can help bridge the gap between product knowledge and process understanding. The concept of QbD integrates the needs and requirements critical to making objective decisions during drug development. It provides a framework to generate a growing but unified knowledge base for your product and key decision points with concrete focused goals. QbD is often thought of as a process to improve efficiency, quality, and productivity only during the manufacturing phase. However, when implemented early in research and development, it can provide enormous benefit to companies seeking to improve knowledge flow and fully utilize prior and new information to gain better insight into the current state of a project.