FedEx aims to keep parenterals truckin'
By Mark DeSorbo
AKRON, Ohio—FedEx Corp., a global provider of transportation, e-commerce and supply chain management services, is now offering parenteral drug manufacturers a way to ship temperature-sensitive products.
TEMP-ASSURE Validated, a service offered by FedEx Custom Critical White Glove Services, Inc., conforms to Food and Drug Administration (FDA) current good manufacturing practices (cGMPs) and includes a validation master plan. It also sets standard operating procedures (SOPs) for the shipment of temperature-sensitive materials.
While it is regulated by the Department of Transportation under Title 49 of the Code of Federal Regulations (CFR), Elaine Chambers, supervisor of sales and marketing, says FedEx developed an understanding of such regulations as CFR 21 for quality, validation and compliance, which are critical to FedEx's life science customers.
"We knew there was a need, and what we wanted to do is make sure that we had a service that helped the pharmaceutical and biotech industries maintain compliance in transportation of products," Chambers says, adding that FedEx hired Hilltown, Penn.-based Integrated Validation Services to develop protocols.
Chambers says the TEMP-ASSURE Validated service helps customers maintain compliance with CFR 21 and other applicable regulations supporting effective cold-chain management. It is ideal for such commodities as pharpharmaceuticals, vaccines, serums, ingredients and the chemicals that are used in the manufacture of items regulated by such organizations as the FDA and the United States Pharmacopoeia (USP).
According to Jim Snider, vice president and general manager of White Glove Services, 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 says. "With this new service, we provide our customers with a validated shipping option that was painstakingly developed to address these needs."
And while it looks like a regular FedEx truck, it is very different from your standard temperature-controlled rig, Chambers says.
Outfitted with either Thermo-King or Carrier temperature control systems, the thermal-mapped vehicles are also 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. Services also include validation procedures and protocols, aligned with quality assurance and control to ensure compliance with cGMPs.
"Some customers need -20 degrees C or below for commodities such as vaccines and serums," Chambers says. "Others have commodities that need protection from freezing or room temperature environments."