INFLUENCE OF (QbR) QUESTION BASED REVIEW TO REVAMP CMC SUBMISSION REVIEW
Journal Title: World Journal of Pharmaceutical and Medical Research - Year 2018, Vol 4, Issue 4
Abstract
QbR for CMC evaluation of an ANDA is focused on critical pharmaceutical attributes. When an applicant submits a QOS of CMC that fully addresses the QbR, this helps to assure product quality and may reduce the number of CMC review cycles by enhancing the quality of submissions and reviews through the use of a standardized set of critical questions. Question-based review (QbR) is a science and risk-based approach to the Chemistry, Manufacturing, and Controls (CMC) evaluation of an Abbreviated New Drug Application (ANDA) to ensure pro duct quality. The QbR questions and this guidance document, in order to adequately assess the safety, effectiveness, and quality of the product. This new QbR system incorporates quality by design and implements risk-based assessment. It recommends that ANDAs be submitted using the Common Technical Document and include the Quality Overall Summary (QOS) that addresses all the QbR questions. This retrospective study explains about the CMC and its challenges and importance of QbR and how QbR will transform the CMC review.
Authors and Affiliations
Dr. Balasubramanian J.
Keywords
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