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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.

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