Transport: Best practice on transport qualification: good distribution practice

Transport validations “were like building a new Eiffel Tower every time,” said Kim Bang Salling, Transport Validation Expert at Novo Nordisk. “The documentation effort and tests were enormous and time-consuming. What we want is to move to something more like the Arc de Triomphe – simple, dependable and robust."

Shipping lane validation or qualification of thermal protection systems – temperature controlled cool boxes if you like - would seem to be a simple enough task. It is not. Each pharmaceutical company and regulatory body use different standards and processes leading to inconsistency across the industry.  This is compounded by the fact that temperature-controlled vehicles, equipment and packaging all present a variety of complex challenges from a regulatory compliance point of view.

Vendors are required to complete operational qualification testing to prove that a thermal protection system will stay at the correct temperature, whatever the varying extremes on the outside. Vendors also don’t have a standard for the specific tests that customers require. This often leads to a huge amount of resources being dedicated to qualification testing, where work is unnecessarily repeated and existing data is not leveraged.

To solve these issues, BioPhorum Drug Substance Storage and Transport workstream has produced a best practice paper – Best Practice on Transport Qualification: Good Distribution Practice– which proposes standardizing shipping lane validation.

By standardizing qualification testing, vendors would have a standard test and the end-user could utilize the results without the need for any repeat testing. As well as advocating one standard approach, the best practice paper provides guidance on interpreting the various tests that different regulatory bodies require.

The team estimates that establishing a standard approach could deliver an annual saving of between $0.5m and $1m per shipping solution, as well as a 50% reduction in resource requirements. Also, product submission timelines could be cut by as much as 6-12 months and the risk of a regulatory finding would also diminish.




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