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Manufacturers bear ultimate cold-chain responsibility

Technological advances made during the past 10 years bode well for temperature-sensitive pharmaceutical products, but a complex distribution chain can still be something of a “black hole.”

Pw 4677 Thermometer

Compared to time and temperature, humidity is often overlooked as a factor in cold chain shipments.

• 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 (see sidebar story below).
• 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. It was made clear by several speakers at the event 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. One speaker said the FDA would like manufacturers to monitor distributors and take greater responsibility for the entire supply chain.

Arminda Montero, distribution QA program manager, global pharmaceutical operations at Abbott, acknowledged that responsibility from a manufacturer’s perspective. “There are numerous handoffs in the pharmaceutical chain, but customers only know the manufacturer’s name. We’ve had customers call us about possible temperature excursions. 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 cold chain distribute temperature-sensitive 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, as evidenced by the growing involvement in this sector by carriers such as American Airlines Cargo, FedEx Custom Critical, UPS Healthcare Logistics, and Delta Cargo.

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