INTRODUCTION

This chapter is a companion document to Viral Safety Evaluation of Biotechnology Products Derived from Cell Lines of Human or Animal Origin 〈1050〉, which was adapted, essentially unchanged, from the International Conference on Harmonization Q5A. This chapter provides users with practical guidance regarding the design, evaluation, and characterization of viral clearance procedures. The chapter scope is the same as that described in 〈1050〉 and covers biotechnology products for human use that are derived from cell lines of human or animal origin. Viral clearance studies performed according to the principles outlined in this chapter will provide meaningful data about the ability of the overall production and purification processes to remove or inactivate a broad spectrum of viral types that may affect the safety of biotechnology-derived products.