FDA's Pharmaceutical cGMPs for the 21st Century: A Risk-Based Approach and Process Analytical Technology Initiatives are meant to enhance and modernize the regulation of pharmaceutical manufacturing and product quality. As a result of these initiatives and the trend of increasingly complex pharmaceutical products, OGD/GPhA has developed a mock example of pharmaceutical development report for a modified release product. This report illustrates how ANDA applicants can move toward implementation of quality by design (QbD). Through establishing quality target product profile (QTPP), identifying critical quality attributes (CQAs), performing risk assessment, conducting design of experiment, and setting control strategies, quality of generic modified release products is ensured.
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