VIRUS VALIDATION PROCEDURES - PRACTICAL ASPECTS

The Ad Hoc Working Party on Biotechnology and Pharmacy of the Committee for Proprietary Medicinal Products has developed a number of guidance notes for manufacturers intending to submit applications for market authorization in the European Union which includes one dealing specifically with the validation of production processes for the removal or inactivation of viruses. The strategies used to minimize the risk of viral transmission by biological products are: screening the source materials for viral contamination; examining the ability of the production process to remove or inactivate viruses; and examining the final product for evidence of viral contamination. It is concluded that validation studies provide a significant assurance of viral safety when properly carried out, using appropriate relevant and model viruses.