THE RISK-BASED APPROACH IN CASE OF A MATERIAL CHANGE IN PHARMACEUTICAL OPERATIONS

Abstract

Change of material source is very common in the pharmaceutical company. In general, the change of material triggers process validation. In this article, the need and extent of process validation have been discussed considering the risk-based approach. Risk assessment should be performed by comparison between old Vs new material, impact assessment due to material change, and material characterization where applicable. Based on risk assessment, it can be concluded that new material is ‘comparable and usable’ or ‘not comparable but usable’ or ‘not comparable and not usable.’ Accordingly, the need and extent for process validation and stability requirements can be concluded.