Data requirements to support in-use stability claims for veterinary vaccines - Scientific guideline
VeterinaryScientific guidelines
This document outlines the data that should be provided in support of in-use shelf-life claims for veterinary vaccines. It aims to provide a framework which will enable applicants to maintain a consistent approach when generating data in support of allocating an appropriate in-use shelf-life to a veterinary vaccine, based on existing regulatory requirements.
Keywords: In-use shelf-life, in-use stability, potency, microbiological safety