OVERVIEW OF PROCESS VALIDATION FOR LYOPHILLIZED PRODUCTS

Abstract

In the era of freeze drying, the process validation plays an essential role. In January 2011, the U.S. Food and Drug Administration published new process validation guidance for pharmaceutical processes. The new guidance debunks the long-held industry notion that three consecutive validation batches or runs are all that are required to demonstrate that a process is operating in a validated state. Instead, the new guidance now emphasizes that the level of monitoring and testing performed during process performance qualification (PPQ) studies must be sufficient to demonstrate statistical confidence both within and between batches. The discussion in this article discusses an analysis of the critical process parameters and their respective impact on the development of lyophilized parenterals.