(607d) QbD for Generic MR Drug Products


The Office of Generic Drugs ensures the therapeutic equivalence and quality of generic drug products. This is based principally upon a regulatory paradigm that requires pharmaceutically equivalent drug products containing the same active ingredient, dosage form, and strength (among other things), and being bioequivalent to the brand name product. Also under this paradigm, the batch to batch quality of generic drug products is ensured based upon batch release testing according to specifications. While this approach has been used with great success toward bringing the availability of high quality of generic drug products, the vast majority of pharmaceuticals approved using this framework have been solution and immediate release oral products, which are inherently simple in design. Drug products however, have increased in design complexity, to encompass modified (oral) release products, among others complex dosage forms. As these pharmaceuticals have increased in their design complexity, approaches adopted to ensure the equivalence and quality of generic drug product pharmaceuticals, must likewise evolve.

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.