Importance Of Chain Of Custody For Commercial Pharma Distribution

By Louis Henry, Quality Manager for Global Services, Peli BioThermal

As more new biologics and cell and gene therapies enter the market, the need for reliable, demonstrable temperature control during shipping has become paramount to pharmaceutical companies’ overarching strategy. Employing tracking technologies capable of monitoring a packaging solution’s internal temperatures is just one facet of this strategy – equally as important is validating a shipment’s integrity along every phase of its journey.

Establishing a chain of custody for temperature-controlled pharmaceutical shipments is critical to determining the root cause of a problem, which can otherwise be difficult to achieve without insight into the environmental and handling variables in play at a specific location. Track-and-trace technologies let recipients know that a temperature excursion has happened; a well-delineated chain of custody lets customers know where the problem arose, the first step to understanding how problems occur and how to fix them.