The use of USDA sensors as calibrated temperature recorders : In view of EU guidelines on GDP for medicinal products for human use

Summary

The EU guidelines on GDP of medicinal products for human use (OJ C 343/1, 23.11.2013) provide guidelines for the transport of temperature-sensitive medicines. Maersk Line wishes to demonstrate how calibrated USDA probes can be used to transport medicines in compliance with GDP compliant transport. The aim of this project is to provide an illustration of how a USDA probe could be used to monitor temperature during transport in a marine reefer container according to EU GDP. The results illustrate that USDA probes may indeed be used to monitor cargo temperatures during transport in a marine reefer container according to the EU GDP of 2013. It remains to be seen whether all shippers of pharmaceuticals accept this procedure: the main concerns anticipated are the max. number of four USDA probes and possibly the lack of traceability to national or international standards.