One of the main changes seen in the recently issued European Commission Guidelines on Good Distribution Practices for medicines for human use (2013/C 343/01) is the emphasis on validating the entire supply chain to ensure that products that are temperature sensitive are subjected to the minimum amount of temperature excursions between manufacture and reaching the patient.
In the past, many distributors have relied on stability data issued by manufacturer’s to excuse temperature excursions during transportation or storage. The problem with this is that, in the past, these excursions were not always recorded therefore it was not possible to be able to assess just how long, accumulatively, a product had been stored or transported outside the manufacturer’s recommended temperature range. If, accumulatively, the product had been stored outside the manufacturer’s recommended temperature for longer than the stability data indicates, there could be implications for the patient that the product is used on.
In order to prevent these unrecorded temperature excursions, and the associated risk to patients, it makes sense that the entire supply chain is kept within the temperature range stated by the manufacturer and that this can be proven.
In order to do this, all storage and transportation methods need to be mapped to ensure that the best locations, packaging and vehicles are used and that the storage and transportation journeys are monitored and any deviations recorded.
PCL are able to offer a range of Cold/Cool Chain Supply Training, expert advice, mapping and validation services. We can review your current setup, modify your current setup or prepare for the implementation of a new system For further information, please contact us on +44(0) 1252 302 342.