Eudralex Volume 3 GUIDELINE ON THE INVESTIGATION OF MANUFACTURING PROCESSES FOR PLASMA-DERIVED MEDICINAL PRODUCTS WITH REGARD TO VCJD RISK
Title:
Eudralex Volume 3 GUIDELINE ON THE INVESTIGATION OF MANUFACTURING
PROCESSES FOR PLASMA-DERIVED MEDICINAL PRODUCTS
WITH REGARD TO VCJD RISK
Origin/Publisher:
European Commission Enterprise and Industry DG, BREY 13/ 092, B - 1049 Brussels (Belgium), http://ec.europa.eu/enterprise/
Document Type:
Guideline
Content:
The aim of this document is to provide guidance on how to investigate manufacturing processes with
regard to vCJD risk. At this time, experience in this area has not reached a point where definitive
guidance can be given. Therefore, the guideline provides advice based on available experience and
other approaches may be acceptable.