(424d) An Example of Quality Risk Management Over Product Lifecycle
AIChE Annual Meeting
2010
2010 Annual Meeting
Comprehensive Quality by Design in Pharmaceutical Development and Manufacture
Quality-by-Design (QbD): Techniques for Quality Risk Analysis and Management Over the Product Life Cycle
Wednesday, November 10, 2010 - 9:30am to 9:50am
An example from a tablet product will be presented where quality for the product lifecycle is monitored in a "soft sensor" sense. A multivariate model derived from process parameters across many unit operations as well as API properties is shown to provide predictions on quality as well as alerts for possible issues.