Extension of the shelf life for the antigen stocks during the type II variation assessment - Scientific guideline
VeterinaryScientific guidelines
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This document includes the CVMP statement on the sterility testing at the end of the proposed shelf-life for variations affecting the extension of the shelf–life for antigen stocks in immunological veterinary medicinal products.
Keywords: Sterility testing, shelf-life, antigen stock, immunological veterinary medicinal product (IVMP)