The EMA and FDA assess QbD

“The European Medicines Agency (EMA) and the United States Food Drug Administration (US FDA) have published a joint question and answer document that outlines the conclusions of their first parallel assessment of quality-by-design (QbD) elements of marketing-authorisation applications.

Quality-by-design is a science- and risk-based approach to pharmaceutical development and manufacturing that was introduced a few years ago in international guidelines intended for the pharmaceutical industry. QbD involves the use of statistical, analytical and risk-assessment methods to design and develop pharmaceutical compounds and manufacturing processes to ensure the quality of the manufactured product.

. . .

The objective of this parallel assessment is to share knowledge, facilitate a consistent implementation of the international guidelines on the implementation of the QbD concept (International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH) guidelines Q8, Q9, Q10 and Q11) and promote the availability of pharmaceutical products of consistent quality throughout the European Union and the US.”

At BioProduction this year we have a dedicated QbD track:
QbD: Development through to Biomanufacturing

At this year’s event we have case studies highlighting the successful implementation of QbD; advice on how to get your QbD programme passed by the regulators; and the implementation of QbD for upstream processing.

Our QbD speakers include:

  • Dr Mark Uden, Head of Biopharm Process Research, The Biopharm R&D Unit, GlaxoSmithKline, UK
  • Dr Patrick Gammell, Principal Development Scientist, Pfizer, Ireland
  • Dr Alex Eon-Duval, Project Coordinator, Biotech Process Sciences, Merck Serono SA, Switzerland
  • Dr Brij Patel, Deputy Manager and Assessor, MHRA, UK

For more information about BioProduction 2013 and what you can learn from our QbD expert speakers, visit our website

Leave a Reply