Practical application of QbD for vaccine production

In Regulation and Policy by Freya SmaleLeave a Comment

download, QbD, vaccine production

What is QbD?

  • Understanding of Product and Manufacturing Process starting with Product Development
  • Define the desired product performance and identify critical quality attributes (CQA's)
  • Design process to meet the requirement
  • Continually monitor and update its manufacturing process to assure product Quality
  • Quality is not being tested into products, rather quality is built in by design

This presentation from the World Vaccine Congress Lyon focuses on:

  • Historical perspective
  • Quality by Design
  • Basic Preamble
  • Relevance to analytical development
  • Case Studies
  • Conclusion

Why not download the full presentation and discover more about Practical application of QbD for vaccine production, including:

· Recent FDA and ICH guidance focused on the need to implement quality systems based on relevant data and enhanced understanding: how integrating QbD concepts can demonstrate these requirements 

· How a QbD approach can support the systematic accumulation of product and process understanding, and aid in ensuring robust and consistent processes, expedited development and facilitate favourable regulatory review

· Case studies: demonstrating the application of QbD to analytical methods and how some of the QbD tools can be applied to vaccine through their lifecycle

Dr Dicky Abraham, Director Vaccine Manufacturing Sciences and Commercialization, Merck & Co

Download the full presentation here >

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