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.
- QbR White Paper
- QbR Quality Overall Summary Outline (FDA Archive)
- Model Quality Overall Summaries
- OGD Update on Question-based Review Submissions
- CMC Microbiology
- Question-based Review (QbR) for Sterility Assurance of Aseptically Processed Products: Quality Overall Summary Outline (PDF - 25KB)
- Sterility Assurance - Quality Overall Summary (SA-QOS) Outline for Terminally Sterilized Products (PDF - 21KB)
- QbR for Sterility Assurance of Terminally Sterilized Products: Frequently Asked Questions (PDF - 115KB)