Reply To: EU guideline on shipping and temp monitoring (536/2014)
April 11, 2023 at 11:09 amI really appreciate the replies! I realize I should have been more specific with the original question. The temp monitoring requirement is clear for frozen, refrigerated and controlled ambient materials.
Does anyone have thoughts on how this EU guideline applies to products that have historically shipped “uncontrolled ambient”? No temperature monitor or qualified passive shipper?
Do Sponsors now need to temperature monitor even uncontrolled ambient products that have supporting stability data to allow for uncontrolled ambient shipping?
