[Ed Groleau]

Reply To: EU guideline on shipping and temp monitoring (536/2014)

Yes, that has been my interpretation and recommendation that all shipments need a temp monitoring device. I have heard arguments that a shipper validated to maintain conditions for x hours can negate the need for a monitor but if you talk to engineers doing the testing or the companies that manufacture them the shippers are “qualified” not “validated”. Unless you can get a guarantee of validation to maintain conditions it’s safer to include the monitor and then not worry about fighting over that distinction.