Question-Based Review: An FDA Reviewer's Perspective

The Office of Generic Drugs (OGD) fully implemented Question-based Review (QbR) in 2007 with the broad goal of encouraging sponsors to include quality-by-design (QbD) principles in their product and process development and to communicate this knowledge in their submissions. In light of this goal, OGD outlined the following four major benefits that the QbR platform would bring to the chemistry, manufacturing, and controls (CMC) review process (1, 2):

Ensure product quality through product design and performance-based specifications
Facilitate continuous improvement and reduce CMC supplements through risk assessment
Enhance the quality, transparency, and consistency of reviews through standardized review questions
Reduce CMC review time when applicants submit a quality overall summary (QOS) that adequately addresses the QbR questions.