What Is Quality By Design (QbD) – And Why Should You Care?

Proper implementation of QbD can potentially provide three main benefits for development:

• More efficient use of development time and costs
• Ability to meet FDA submission guidelines and expectations
• Reduced approval times – and fewer queries – from the FDA

Likewise, QbD can potentially provide significant benefit in manufacturing. Even after your drug has gained FDA approval, routine QC testing may detect an out of specification (OOS) result. For a company that did not use a QbD approach, an OOS result can mean a seemingly endless quest to find the root cause. Absent the data that QbD provides, test results may be suspect, questions difficult to answer, and long delays inevitable. Without knowing where to look, your team may resort to a trial-and-error approach to resolve any OOS occurrences.