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Doses in Cleaning validation

Which dose is to be considered for calculations of maximum allowable residue in the next product when dose is recommended for chidren and adults?

Also when dose is in divided doses what value will be considered for calculations?

:slight_smile:
Thanks in advance!!!

The dose that has to be considered is the minimum pharmacological dose, that is, the minimum among pediatric dose and the minimum dose recommended in the product leaflet. If the tablet is scored and the posology allows for breaking the tablets, use the minimum allowed partition to calculate the MACO.

Regards

Alfred