Manufacturers bear ultimate cold chain responsibility

• Before agreeing to long-term contracts, a military supply center now requires manufacturers to include validated packaging and temperature monitoring process details in their shipments.

• Extended stability studies are desirable for manufacturers shipping pharmaceutical and biologic products through cold chain distribution.

These were among the nuggets gleaned from the 7th Cold Chain Distribution for Pharmaceuticals conference Sept. 21-23 in Philadelphia (see p. 20). What I heard frequently was that no matter how many companies handle your product through the pharmaceutical distribution chain, if the product is not effective—perhaps due to time and/or temperature excursions—the ultimate responsibility that a safe, effective medication reaches a patient rests with the manufacturer.

Arminda Montero, distribution QA program manager, global pharmaceutical operations at Abbott, acknowledged that responsibility from a manufacturer's perspective. She noted, "It's important to follow current Good Manufacturing Practices and Good Distribution Practices.” Montero was one of several speakers who stated, “colder isn't always better,” when it comes to how companies throughout the chain store and distribute cold chain pharmaceuticals.

Representatives from refrigerated and/or frozen cargo carrier companies made it clear they want to do a good job delivering medications for manufacturers. Even though the pharmaceutical business may be small compared to other industries, these carriers know there's money to be made in this sector, as evidenced by the growing involvement by carriers such as American Airlines Cargo, FedEx Custom Critical, UPS Healthcare Logistics, and Delta Cargo.

Another interesting tidbit came from one event attendee who recommended I keep on the alert for medical device products requiring cold chain distribution.