CPSA Shanghai 2011
Changing Paradigm in Drug Discovery & Development:
East Meets West
April 13 - 16, 2011
Renaissance Shanghai Pudong Hotel
Shanghai, China
Abstract
Thursday AM - Parallel Session II
PAT Application in a QbD Paradigm
Kevin J. Bittorf, Ph.D.
Chemical Engineering, MBA, Professional Engineer,
Associate Director CMC Process and Alliance Management
Vertex Pharmaceuticals
This is another exciting year for the pharmaceutical industry; Quality by Design (QbD) and Process Analytical Technology (PAT) are now widely accepted in the Western Pharmaceutical Industry. The FDA’s Office of New Drug Quality Assessment (ONDQA) CMC pilot program has been around for 7 years and the EMEA has been presenting on PAT since early in the last decade.
In accordance with ICH Q8/9/10 and the FDA QbD initiative, companies are adding more and more PAT equipment, installing more sophisticated control systems, and moving to real-time release. Throughout this process, many questions have come to light. How is PAT incorporated into the overall control strategy and validated? How is PAT used for real time release, and when is real time release worthwhile? This seminar will cover new trends in PAT technology, validating PAT equipment and using PAT in real time release (RTR).