Eudralex Volume 3 GUIDELINE ON PRODUCTION AND QUALITY CONTROL OF ANIMAL IMMUNOGLOBULINS AND IMMUNOSERA FOR HUMAN USE

Title:
Eudralex Volume 3 GUIDELINE ON PRODUCTION AND QUALITY CONTROL OF ANIMAL IMMUNOGLOBULINS AND IMMUNOSERA FOR HUMAN USE

https://www.gmp-compliance.org/files/guidemgr/guideline-production-and-quality-control-animal-immunoglobulins-and-immunosera-human-use-revision-1_en.pdf

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 guideline provides guidance for the starting material, the manufacturing and quality control of animal immunoglobulins and immunosera for human use. Specific attention is given to the animals used in production, the antigens for immunisation, the characterisation of the animal immunoglobulins/immunoserum during development and the viral safety of these products.

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