Investigation of manufacturing processes for plasma-derived medicinal products with regard to variant Creutzfeldt-Jakob disease risk - Scientific guideline

This document provides guidance on the investigation of manufacturing processes with regard to variant Creutzfeldt-Jakob disease (vCJD) risk.

Keywords: Creutzfeldt-Jakob disease (CJD), human transmissible spongiform encephalopathies, plasma-derived medicinal products, variant CJD, blood infectivity, transmissibility

Current effective version

Guideline on the investigation of manufacturing processes for plasma-derived medicinal products with regard to variant Creutzfeldt-Jakob disease risk

Adopted Reference Number: CPMP/BWP/CPMP/5136/03 Legal effective date: 01/10/2004