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FDA’s QUALITY ASSESSMENT SYSTEM

This article was originally published in The Gold Sheet

Executive Summary

...could include an expanded role for annual product reviews in the regulation of manufacturing changes as the new CMC review paradigm takes concrete form. In October, a large group of FDA and industry representatives gathered at a workshop designed to help guide the agency in addressing the practical issues and challenges involved in implementing the many dimensions of the quality assessment effort. The questions surrounding the concepts of design space, the pharmaceutical development report, the quality overall summary and the regulatory agreement – how they should be defined, reviewed, updated and interlinked – were among those that the participants wrestled with in trying to move the effort forward. [Summary reports delivered at the quality assessment workshop from breakout sessions on: * pharmaceutical development * CMC regulatory processes * CMC regulatory agreements * communication * design space * quality overall summaries * innovation and continuous improvement * post-marketing changes * integration of review and inspections * pharmaceutical assessment practices, and * quality-by-design implementation are included.]
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