A central theme that emerged from the conference is that process validation is no longer, and should not be about “the 3 successful batches”. The FDA is moving away from mere in-process and finish-product inspection, but wants the industry to show proof that quality, safety and efficacy is being designed into the product, and to ensure that there is ongoing assessment of process data vs. variability through continued process monitoring and control. Many pharma companies are starting to incorporate various approaches including QbD, risk assessment and lifecycle management into their process validation strategies to be aligned with the FDA guidance.

Quality by Design and the new FDA Process Validation Guidance. How do they fit together? Read more about our 2012 panel discussion.

"Great conference with many valuable topics covered." - M. Kane, Associate Director, Process Statistics, HGSI