Section Iii Evaluation And Qualification Criteria

Guideline on Virus Safety Evaluation of Biotechnological ...

(i) the criteria for and the extent of viral safety evaluation studies, that are required prior to and during clinical development. (ii) the extent to which manufacturers are able to refer to in-house experience concerning virus safety evaluation. (iii) the risk assessment which should form part of the safety evaluation. 1. INTRODUCTION

  Evaluation, Criteria