Tag Archives: drug product quality

FDA Perspective on Quality by Design (QbD) in Pharmaceutical Development

Over the last five years, FDA and ICH quality initiatives created a paradigm shift in pharmaceutical discovery, development, and manufacturing.  At the 17th International Process Development Conference, Christine Moore gave a presentation on the FDA perspective on Quality by Design (QbD) in pharmaceutical development.  During her presentation, Christine discussed the advantages that the U.S. Food and Drug Administration (FDA) believes Quality by Design offers, including: Continue reading