Virus Validation Studies: the Design, Contribution and Interpretation of Studies Validating the Inactivation and Removal of Viruses

Status Last revised February 1996 Previous titles/other references Validation of Virus Removal and Inactivation Procedures (III/8115/89) / CPMP/BWP/268/95 Additional Notes This guideline discusses the need for, and the contribution of, viral validation studies towards the viral safety of biological products, providing guidance on the design of a validation study including the choice of viruses to be used and on the interpretation of the data. This guideline was originally adopted in February 1991 under the title Validation of Virus removal and Inactivation Procedures. It was revised to take into consideration the ICH guideline Q5A Quality of Biotechnological Products: Viral Safety Evaluation of Biotechnological Products derived from Cell Lines of Human or Animal Origin (CPMP/ICH/295/95)