Eudralex Volume 3 NOTE FOR GUIDANCE ON PRODUCTION AND QUALITY CONTROL OF ANIMAL IMMUNOGLOBULINS AND IMMUNOSERA FOR HUMAN USE
Title:
Eudralex Volume 3 NOTE FOR GUIDANCE ON PRODUCTION AND QUALITY CONTROL OF ANIMAL IMMUNOGLOBULINS AND IMMUNOSERA FOR HUMAN USE
Origin/Publisher:
European Commission Enterprise and Industry DG, BREY 13/ 092, B - 1049 Brussels (Belgium), http://ec.europa.eu/enterprise/
Document Type:
CPMP Note
Content:
This note includes information about species used for the production of animal immunoglobulin/immunoserum for human use as well as chracterisation of Immunoglobulin/Immunoserum, points to consider in manufacturing, final bulk batches, release testing and potentialvirus contaminations.