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EU Commission Guidelines on Good Distribution Practice of IMP

Posted by Kate Enright on Mar 1, 2016 11:00:00 AM

Capture-3-161488-editedOver the past few years there has been a notable increase in the number of temperature-controlled clinical supplies being transported all over the world. This increase can be attributed to the fact that a larger number of clinical trial drugs being tested today are of a biological nature. However, as discussed on the Fisher Clinical Services INSIGHTS blog, until recently little thought was given to ambient drug (generally set to be stored within 15°C – 25°C) being transported through a temperature controlled method as well.

Biologics generally need to be stored and transported in refrigerated conditions (between 2°C – 8°C) for the material to be and remain fit for use. For this reason, Sponsors want reassurance that the temperature status of the drug is safe and recorded at all times. Of course, this is also true for the storage and transportation of frozen material. 

Recently our US team implemented the use of pre-qualified shippers for both ambient and CRT conditions to ensure the integrity of the drugs throughout the chain of custody. However, The European Commission Guidelines on Good Distribution Practice of Medicinal Products for Human Use has now taken the first step in requiring the monitoring of ambient drug product, as well as frozen and cold.

The guidelines describe that regardless of the chosen mode of transportation (air, road, sea, rail or a combination); it should be possible for the Sponsor to demonstrate that:

  • The medicines have not been subjected to conditions during transportation that may compromise their quality
  • The temperature limits were maintained within the defined parameters as described on the packaging information of the drug

To that end, it is not enough to ensure that clinical supplies are appropriately protected during transportation, but during all steps of the supply chain which includes the manufacturing of the IMP through primary/secondary packaging, handling of IMP, transportation to the investigator site, and indeed storage at the clinical site itself.

What does this mean for our industry? Change is coming. Using pre-qualified ambient and CRT shippers help to maintain the integrity of room temperature drug in transit. And while all clients aren’t requesting pre-qualified shippers for ambient and CRT shipments, it’s only a matter of time before this becomes an industry-wide practice.

To learn more about risk management and how to select the correct transport provider to safely move your irreplaceable biospecimen collection, download our InfoPoster!

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