Gert Ragnarsson, Director of the Swedish Medical Projects Agency, discusses the biggest milestones in QbD over the last decade, including:
• The establishment of harmonized guidelines
• The formation of the EMA
• The recent document published by the FDA, which is a significant step in dealing with advanced formulations
Ragnarsson also looks to the future growth of generics and the effects QbD and PAT will have on that market.