When shipping API from the API supplier to the drug product manufacturing site, is it allowable to send a representative side sample to go straight to the receiving lab, or do the receiving side have to sample the API themselves?
It is always preferred to perform the sampling of API at the receiving end by the drug product manufacturer. This is to ensure that the sample represents the API batch received at the drug product manufacturing site.
So far as I know, it is indeed that sampling by the API manfactuer staff then transfer the sampl along with the FPP shipment is allowed.
Yes, it is allowed to do sampling by the API manufacturer. However, it is always preferred to perform the sampling of API at the receiving end by the drug product manufacturer.
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