Is QbD is the right choice for your product?

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 …

Practical application of QbD for 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 …