ASAP Applications in Generic Products

ASAP Applications in Generic Products

Bryan Wicks, Ph.D.
Associate Director
Boehringer Ingelheim Pharmaceuticals Inc.

The typical generic pharmaceutical business model requires ascertaining as much product understanding as possible in a drastically shortened development time.  With ever changing regulatory requirements, product knowledge and robust development processes are critical in the manufacturing of a sustainable quality product.  The generic industry benefits from tools that provide substantial scientific information relatively quickly relating to development, investigation and change control issues pertaining to long term life cycle issues of commercial products. 

The Accelerated Stability Assessment Program (ASAP) is a tool that has been recently applied within the generic industry.  The ASAP approach has shown utility in generating valuable information within a minimal timeframe.  In this presentation, a case study illustrating the application of ASAP for the evaluation of changes to an active pharmaceutical ingredient’s (API) physical properties and the resultant impact on drug product stability will be discussed.