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Approval of Veterinary Biological Products

Water quality statement from local authorities certifying compliance with effluent waste regulations [Pg.147]

Application for at least one Product License supported by an outline of production, information on master seeds/master cells and bio-containment if applicable, and protocols for studies of host animal safety and efficacy [Pg.147]

Test reports and research data sufficient to establish purity, safety, potency, and efficacy of the product [Pg.148]

Legends designating facilities used for each step [Pg.148]


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