Abstract

Process validation has been an integral part of the cGMPs. Proving documented evidence of process adequacy has been considered as an organizational milestone for years. The same set of justifications live through multiple inspection scrutiny during the products lifecycle. Hence it has always been, and continues to be, a mechanism to provide excessively convincing proof of the process being in a qualified state at all times. If we consider the 1987 process validation guidance as a first step, the 2011 guidance is indeed a new approach needing a different mindset. The recent regulatory inspection trend indicates continued difficulties in adhering with the latest 2011 regulations. Let’s understand the guidance purpose and consciously embrace them. New process validation practitioners should find it easier to adopt the 2011 guidance and excel in practice as they are not encumbered with the previous approaches.