Method of CMC review for generic drugs (ANDAs) implemented by the FDA. According to the agency, "The QbR . . . incorporates the most important scientific and regulatory review questions that focus on critical pharmaceutical attributes essential for ensuring generic drug product quality. The QbR serves two purposes for the CMC assessment of ANDAs. First, it provides a guide to the reviewer in the evaluation of whether a product is of high quality and in the determination of the level of risk associated with the manufacture and design of the product. Second, it provides transparency to sponsors about the logic that reviewers invoke in their CMC reviews."
Cheryl Abernathy and Bryan Sasbon, Quality Assurance Operations Manager, Ropack Pharma Solutions; QA Director & Regulatory Affairs, Ropack Pharma Solutions||September 8, 2016 Embracing the process as a means to a strong quality culture