Regulatory affairs and biotechnology in Europe: III. Introduction into good regulatory practice — Validation of virus removal and inactivation

摘要

This paper provides for an overview on the practical consequences of the EC guideline (III/8115/89): Validation of Virus Removal and Inactivation. This guideline can only be used as a blueprint in combination with other specific guidelines, especially those concerned with EC recommendations during production and quality control for various biotech products.