11/12 October 2022
In a recent blog of the Medicines and Healthcare products Regulatory Agency (MHRA), the inspectorate looks at one aspect of the new Annex 16 - the handling of unexpected deviations.
In the blog, MHRA is illustrating its opinion with an example of a short-term temperature excursion during the transport of a product from a third country to the EU:
"The label claim for the product is 'store below 25°C', and the excursion was up to 29°C for 3 days. Existing stability data demonstrated no issues when stored at 30°C for up to 3 months. This situation would fall within the scope of 'unexpected deviations', provided that the shipment process was designed to comply with the registered conditions (i.e. that the excursion could be reasonably described as 'unexpected')." That does mean that the Qualified Person (QP) would be in a position to certify the batch.
However, MHRA states, "if there were no controls over shipment conditions, then the use of stability data as a 'routine' means to justify such an excursion would not be acceptable."
To find out more please see the MHRA nspectorate's blog "Handling of unexpected deviations".