Abstract

Complexity in Pharmaceutical Systems

Brian Carlin, Director, FMC BioPolymer

For over a decade regulatory authorities have defined a process as well understood1 when:- •all critical sources of variability are identified and explained •variability is managed by the process •product quality attributes can be accurately and reliably predicted The interplay of complex raw materials with complex pharmaceutical systems means that not all critical sources of variability can be identified at time of filing. It therefore follows that variability may not be fully managed by the process and that the product quality attributes cannot be absolutely guaranteed. Methods to minimize the impact of such uncertainty on quality attributes, and how to demonstrate the relevant diligence on filing, will be discussed. 1Process Analytical Technology (PAT):What’s in a name? D. Christopher Watts, Ph.D. Office of Pharmaceutical Science, CDER, FDA Science Seminar Series for the Office of Commissioner April 9, 2004