Question-Based Review for CMC Evaluations of ANDAs
The Office of Generic Drugs (OGD) is developing a question-based
review (QbR) for the Chemistry, Manufacturing, and Controls (CMC)
evaluation of an Abbreviated New Drug Application (ANDA) that is
focused on critical pharmaceutical quality attributes. The QbR
initiative began in early 2005 with the development of a revised
review template and is approaching the early implementation phase as
we gain feedback through wide internal and external discussions.
The QbR will transform the CMC review into a modern, science and risk-based
pharmaceutical quality assessment that incorporates and implements the concepts and
principles of the FDA’s Pharmaceutical cGMPs for the
21st Century: A Risk-Based Approach and
Process Analytical Technology initiatives. The main objectives of this enhanced
review system are to:
- assure product quality through design and performance-based specifications,
- facilitate continuous improvement and reduce CMC supplements through risk assessment,
- enhance the quality of reviews through standardized review questions,
- reduce CMC review time when sponsors submit a quality overall summary that addresses the QbR.
OGD’s QbR was designed with the expectation
that ANDA applications would be organized according to the Common
Technical Document (CTD), a submission format adopted by multiple
regulatory bodies including the FDA. Generic firms are strongly
recommended to submit their ANDAs in the electronic CTD format to
facilitate the implementation of the QbR and to avoid undue delays
in the approval of their applications. OGD will keep all
stakeholders informed of the changes through this office website and
our continued dialogue with the Generic Pharmaceutical Association,
and other stakeholders.
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Date created: August 31, 2005, updated August 10, 2007 |