FedEx opts for cGMPs in shipping temp-sensitive materials

FEB. 9–ANKRON, Ohio–FedEx Custom Critical, Inc., a provider of expedited time-critical shipments, now offers a validated solution for temperature-sensitive shipments through its latest service, TEMP-ASSURE Validated.

This shipping option conforms to current Good Manufacturing Practices (cGMPs) and includes a validation master plan. It also sets standard operating procedures for the shipment of temperature-sensitive materials.

TEMP-ASSURE Validated was developed to address increasing concerns about the proper handling of temperature-sensitive materials. It also facilitates compliance for customers regulated by organizations such as the Food and Drug Administration (FDA) and the United States Pharmacopoeia (USP).

Customers receive a validated service that includes thermal-mapped vehicles, redundant data retention and hard-copy data logs documenting the temperature of the cargo hold during a shipment. This service also includes validation procedures and protocols, ensuring optimal quality according to cGMPs.

In addition to thermal-mapped vehicles, specialized care-in-handling and temperature-control equipment, TEMP-ASSURE Validated vehicles are equipped with a National Institute of Standards and Technology (NIST) traceable data logger and temperature probes that record temperatures at different areas of the cargo box.

According to Jim Snider, vice president and general manager of White Glove Services(R), TEMP-ASSURE Validated provides a missing compliance link in the cold-chain, ensuring proper shipping temperature and record keeping while products are in transit.

“Our objective was to address the regulatory and quality needs of our customers,” Snider said. “With this new service, we provide our customers with a validated shipping option that was painstakingly developed to address these needs.”


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