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What needs to be taken into ac when manufacturing Veterinary Medicinal Products for different species in the same facility?

02/07/2021 | 3154

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Reply:

The guideline on setting health-based exposure limits indicates that the carry over limit should generally be derived using the human HBEL.
However, in cases where there is concern relating to known susceptibility of a particular species (e.g. monensin in horses) the HBEL approach should take into ac knowledge of specific animal toxicity when evaluating products manufactured in shared facilities/equipment.

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