We plan to ship 5 vials in a Kit to a US phase 1 clinical trial.
The Kit will have a unique serial number as part of the secondary packaging.
The vials have primary label with the lot number. (there is no unique vial number)
One vial from the kit is required for one patient dose.
Five patients will be dosed from one kit.
The kit is not patient specific.
The clinical site is expected to document the kit number and vial lot number dosed to a patient. No IRT is used for this phase 1 trial.
Is this OK for a US trial?
The reason I ask is: the packaging CMO says that this is not PIC/S compliant for US.
Does PIC/S apply to the US?
Any help is appreciated!