- 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 perspectiveâ€¦. only hear about the disastersâ€¦ and not the success
Dreamâ€¦ The process is designed and controlled such that product always meets acceptable quality attributes ensuring safe and efficacious product every time â€¦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