ICH Q5A (R1) Quality of biotechnological products: viral safety evaluation of biotechnology products derived from cell lines of human or animal origin

Table of contents

This document considers testing and evaluation of the viral safety of biotechnology products derived from characterised cell lines of human or animal origin. It outlines data that should be submitted in the marketing application/registration package.

Keywords: Viral safety, cell lines qualification, biotechnology, virus clearance

Topics

How useful was this page?

Add your rating
Average
2 ratings
1 rating