[Anonymous]

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

For QP certification then one of the requirements within Annex 16 is the following:
The finished product batch has been stored and transported under the required conditions, (Section 1.5.7 ii)
Therefore without a monitor this is extremely difficult to prove as extremes of weather can affect the temperature.
This question has been raised in several EU forums over the years and the expectation has always been that temperature monitors are used so that the shipping temperature can be confirmed.