I often get asked “can the shipper be validated, please?” The answer to this question is ‘no’. A shipper cannot be validated within a clinical trial supply chain environment.
This answer may come as quite a shock at first glance. If a shipper cannot be validated, then why do we perform all the rigorous testing to document expected shipper performance in the field? However, the answer lies within the definition of the term “validation”.
A temperature controlled shipping system can be “qualified” for the supply chain but it cannot be “validated”.
The term “Validation” is defined as a documented testing, performed under highly controlled conditions, which demonstrates a process consistently produces a result meeting predetermined acceptance criteria. Whereas, the term “qualification” ” is defined as documented testing that demonstrates with a high degree of assurance that a specific process will meet its pre-determined acceptance criteria. 1
When we consider a clinical supply chain, it is far from being a highly controlled environment. Events can, and do, take place that are beyond our control – natural disasters, extreme weather, mishandling, or cancellation of flights are just a few examples!
Think of the events back in 2010 where the Icelandic volcano, Eyjafjallajökull, erupted. Although relatively small for volcanic eruptions, it caused enormous disruption to air travel across western and northern Europe, grounding planes for almost a week.
Also, consider the North American cold wave in early 2014. Temperatures fell to unprecedented levels and low temperature records were broken across the United States. The low temperature at O'Hare International Airport in Chicago registered −16 F (−27°C) on January 6, 2014. During this extreme weather period, O'Hare and Midway Airports cancelled 1200 flights.
Furthermore, within a clinical supply chain there are often be many hand-offs to 3rd parties which are outside of our immediate control – integrators, ground handlers and airline personnel to name but a few. The training and attention to detail of these personnel may not be at the level expected within a pharmaceutical environment. Occasionally, even with the best processes in-place, shipments get mishandled such as being dropped or placed into the wrong temperature environment.
In conclusion, we must live with a degree of uncertainty in the supply chain outside of our immediate control. During the qualification process we can build in contingency or a certain level of ‘assurance’ for unexpected events; however, it cannot encompass all scenarios. For this reason, we must consider a temperature controlled shipping system “qualified” not “validated”.
1Rafik H. Bishara, PhD “Qualification Versus Validation and Good Cold Chain Management Practices” Pharmaceutical Manufacturing and Packing Sourcer, Autumn 2005 issue, pages 102, 104, 106. © 2005 Samedan Ltd