QRM Process

QbD: Regulatory and Scientific Possibilities and Challenges Podcast

Dec 02, 2013


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.

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