466 Application of Quality by Design in API Process Development

Wednesday, October 31, 2012: 12:30 PM
Allegheny II (Westin )
Modernization of regulatory processes in the pharmaceutical industry has led to several innovative approaches to risk-based implementation of Quality by Design. Speakers for this session should include topics describing their application of QbD principles with examples of determination of critical process parameters (CPPs), mapping of design spaces (DS), real time process monitoring, and the determination of appropriate control strategies for small and large molecule drug substance processes.

Topical I: Comprehensive Quality by Design in Pharmaceutical Development and Manufacture
Process Development Division (12)

Partha Mudipalli
Email: pmudipal@cephalon.com

Joe Hannon
Email: joe.hannon@scale-up.com

- indicates paper has an Extended Abstract file available on CD.

12:35 PM
(466a) Application of Quality by Design Principles for An Existing Product for the Control of the Dimer Impurity in the Manufacturing Process
Gautam Samanta, Praveen K Sharma, S Srividhya, Kamlesh Pai Fondekar, K R Janardan Sarma, Saurabh Gupta, Grb Ravish and Y Raghuram

12:55 PM

1:35 PM

2:20 PM
(466f) Implementation of Reaction Modeling and Process Analytical Technology in Design Space Development
Daniel Hallow, Michael Fenster, Antonio Ramirez, Robert Wethman and Nathan Domagalski
File available
2:40 PM
(466g) Application of Quality by Design in API Process Development
Nirav Shah, Conny Vikstrom and Erik Johansson