ISPE Glossary of Pharmaceutical and Biotechnology Terminology

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Question based Review (QbR)

(FDA) A review being developed by the Office of Generic Drugs (OGD) for its Chemistry, Manufacturing, and Controls (CMC) evaluation of Abbreviated New Drug Applications (ANDAs), that is focused on critical pharmaceutical quality attributes. The QbR is a concrete and practical implementation of the underlying concepts and principles outlined by the FDA’s cGMPs for the 21st Century and PAT initiatives. It will transform the CMC review into a modern, science and risk-based pharmaceutical quality assessment.

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