Is QbD is the right choice for your product?

In Partnering and Corporate strategy by Freya SmaleLeave a Comment

download, QbD

Is QbD is the right choice for your product?

Reality…

  • GMP failures – 38% increase in product quality defects linked to GMP from 2011
  • 2012 (EMA/MHRA), doubled since 2009
  • Assay issues – variability, not state-of-art
  • Process control failures causing quality failures
  • Regulatory failures – changes introduced that affect product quality
  • Emerging safety issues – not all CQAs identified; inherent limitations in clinical testing
  • Lessons aren't being learnt Warped perspective…. only hear about the disasters… and not the success

Dream… The process is designed and controlled such that product always meets acceptable quality attributes ensuring safe and efficacious product every time …Can this dream be achieved?


Why not download the full presentation and fins out if QbD is the right choice for your product(s)?

  • Making the most out of the validation framework laid out by the regulatory authorities and make effective strategic decisions
  • The importance of risk assessment and understanding the requirements for defining your critically quality attributes
  • Exploring the potential of Design of Experiments QbD and the limitations faced by vaccines: can the tools necessary for QbD be applied to traditional vaccines?
  • Discussion of characterization and variability limitations applicable to QbD
  • Will thorough work lead to reduced long term costs?

Dr Elizabeth Pollitt, Quality Assessor, MHRA

Download the full presentation here >

For more information about this and other topics discussed at the World Vaccine Congress Lyon, subscribe to the Vaccine Nation newsletter, or visit the event website.

For more updates on the vaccines industry, follow us on Twitter: @vaccinenation or join our LinkedIn group: Vaccine Nation

Leave a Comment

Current ye@r *