[Anonymous]

Reply To: Ancillary Supply Management Requirements

For our supply chain, the guideline we use is that we store per commercial label since that is what is approved by the regulatory authority. For any excursion we would reach out the manufacturer. Anything outside of a response by a manufacturer would need to be scientifically based on data. Even for ancillaries like diluents, saline, etc.
If there is no storage condition on the product (I think IV tubing came in without one a while back), we review with quality to gain endorsement that 15-25°C (warehouse temperature) is acceptable until confirmation from the supplier is received. This problem largely went away when we included the temperature criteria in the evaluation of the supply chain/ lane so we most always receive recommended storage conditions now on ancillaries we procure directly.