Reply To: EU guideline on shipping and temp monitoring (536/2014)
April 11, 2023 at 9:06 amHi Josh,
I agree with Ed.
What’s interesting is that the FDA has said they would be OK with Mean Kinetic Temperatures to show opportunities to go out of spec.
The EU has no such inclinations. They’ve said repeatedly that there needs to be a monitor, even if it is a qualified shipper as even the most qualified shipper may not be qualified for the abnormal temperature swings the EU has been having over the past decade.
If you can afford it, always go with a monitor, as inspection outcomes will be so much easier.
Steve
