452573 QbD for Generic Modified Release Drug Products

Friday, November 18, 2016: 9:58 AM
Continental 4 (Hilton San Francisco Union Square)
Yue (Helen) Teng, Office of Lifecycle Drug Products

As stated in the White paper recently published on FDA website - FDA Pharmaceutical Quality Oversight: One Quality Voice, a number of challenges to pharmaceutical quality continue to manifest.  Among all the problems, product recall and defect reporting data is listed as the number one problem.  The high occurrences of problems can be attributed to inherent defects in product and process design; these data further indicate failures in the implementation of manufacturing process scale-up as well as routine production.

FDA’s approach to quality oversight has evolved in recent years, from an emphasis placed on quality control using empirically derived specifications, moving towards an increasing emphasis on in-depth product and process understanding.  However, for a while, a disproportionate amount of regulatory attention is devoted to low-risk products and issues, diverting resources needed for the assessment of high-risk products.  Therefore, risk based Quality by Design (QbD) approach is necessary.  For simply designed immediate release oral products, traditional quality control approach is adequate. However, for more complex modified (oral) release products, risk based QbD approach should be adopted. 

More and more drug products have been developed as modified release dosage forms in order to maintain therapeutic activity for an extended time, reduce toxic effects, protect the active substance against degradation due to low pH, etc.  As these pharmaceutical products have increased their design complexity, approaches adopted to ensure the equivalence and quality of generic drug products, must likewise evolve.  This presentation will focus on the quality assessment of modified release drug products based on their risk level, product design, and process understanding.

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