Quality by design (QbD) is a systematic approach for product and process design and development to ensure predefined product quality. Although the recent ICH guidelines (Q8-Q10) have provided an outline for development of “high quality” pharmaceutical products based on a comprehensive QbD approach, there are very few publications describing how to implement the QbD principles on the development of generic drug products. This presentation will discuss a case study of the pharmaceutical development report for an immediate-release drug product, which was developed by the FDA/Industry Working Group in 2010. This example built on the Conformia ACE case study by treating that product as the reference product for development of a generic product. The purpose of this case study is to illustrate how to implement the principles contained in ICH guidelines (Q8 , Q9, and Q10) during the development of generic drug products.
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