Looking back over the summer, my recollection is one of pretty cool and damp weather, but records do show that we at least had a few hot days. And with hot days come temperature deviations particularly during transportation and looking back over the deviations from this year one common theme seems to arise and that is issues with inbound goods from manufacturers or large pre-wholesalers.
On several occasions this year inbound deliveries have been rejected due to elevated temperatures recorded at goods in. Some of the responses received from the suppliers have been troubling:-
- One suggested that because the products were GSL they assume it is going into retail and therefore don’t apply temperature control. My understanding of GDP and GMP is that the licence holder is responsible for the safe transportation of goods to the point of delivery to the customer’s premises, there is no differentiation depending on the status of the customer. Even this was the case they must surely have evidence for other products and channels?
- One questioned the testing process at goods in. It is accepted that the spot testing of the temperature of goods being received is not perfect and certainly does not indicate the duration of any excursion but in the absence of other evidence I am not sure what other controls could be applied. In this instance the supplier has been unable or unwilling to provide any evidence or summary risk analysis of transportation during hot weather.
- One even suggested that they had dispensation from the MHRA in this area, again not supported by any evidence.
We always talk about protecting the product for the end user, it is a bit worrying when there is lack of control right at the outset.