FedEx Custom Critical offers a vendor-neutral qualification process for cold-chain shipping

Temp-Assure service evaluates drug, packaging and shipping lane for commercial-scale deliveries

The Temp-Assure service, newly offered from FedEx Custom Critical (Uniontown, OH) makes use of qualification expertise within the FedEx organization to provide validation of the choices made by manufacturers for packaging, shipping process and logistics provider. “While we love it when we’re the carrier of choice,” says Karl Kussow, manager, quality, at Custom Critical, “we’ll apply this service equally to any shipping lane and any provider.”

Qualifying how products are transported can be part of an FDA approval process, and often is required for commercial-scale deliveries to meet the standards of various national and international regulatory authorities--in particular, the newly formalized EU Good Distribution Practices (GDPs) guidelines. Manufacturers have a growing number of options for shipping: active (powered) refrigeration containers or passive, units employing dry ice or phase-change materials; “pre-qualified” shipping containers; and a wide variety of warehousing, air or ground transportation, and monitoring services. Kussow says that a full-fledged, risk-based analysis will take the characteristics of the product itself into consideration, along with the packaging and delivery options. “FDA, as well as international bodies like Health Canada, the EU and many other countries are looking more closely at all products’ transportation, both refrigerated and ambient,” he says. “Whether or not a shipper chooses to monitor each individual shipment, it’s a wise course of action to verify shipping conditions frequently.”

The service can be arranged to be conducted in a matter of days, and the evaluations performed over a period of weeks or months, depending on the scale and variability of the transportation service being sought.