Reply To: EU guideline on shipping and temp monitoring (536/2014)
April 11, 2023 at 12:41 pmHi Josh,
For uncontrolled ambient temperature IMP, that you have very good stability on (when I say good stability, I mean 15 to 30C), then you can get away with not putting a temp monitor into the shipment as long as your confident the materials will remain between your temp ranges. You may get dinged on this on an EU regulatory inspection, but as long as you have good controls in place and you’re using common sense (and not going into sub-saharan Africa), you should be good to go.
Steve
