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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.

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