IFPAC: Analyze This

If you're into PAT and QbD, you'd be hard-pressed to find a trade show with more relevant sessions and productive discussion than the annual IFPAC show. Over the years IFPAC has gotten more and more pharma-centric, and this year's Baltimore event is no different, with GSK's Theodora Kourti getting things started, followed by FDA's Vincent Vilker and Helen Winkle, and then a host of other pharma presenters over the next few days. Click on the preliminary program link on the IFPAC home page.

QbD for Generics: Considerations and Questions

Quality by Design has great relevance for generic drug manufacturing, and this article is a summary of discussions held last summer with FDA's Lawrence Yu (of the Office of Generic Drugs) and Helen Winkle, and representatives of the generics industry. Most of the discussion deals with general thoughts and questions, and thus it's a useful overview of current understandings and questions surrounding Quality by Design for non-generics manufacturers as well.

--Paul Thomas