Principles and Methods of Process Validation Studies for Virus Removal and Inactivation

Abstract

A common feature in the manufacture of all pharmaceuticals whose production has involved the use of animal material is the risk of contamination of viruses. Viral contamination can occur through direct contamination of the starting material itself or by introduction of viruses through the use of animal material in the production process e.g. bovine serum in cell culture. Process validation studies for virus clearance and inactivation in association with rigorous testing of the starting material and product throughout the process provide an essential level of assurance that a particular product is safe and free from viral contamination.