Shippers should first examine their product characteristics and processes for commercialization. "Until you understand the environmental hazards and impact on your molecule," Hutchinson says, "you don't have a good feel for what it takes to design your cold-chain management system." With that intelligence in hand, companies can proceed to review procedures for packaging, monitoring and control and employee training, as well as agreements with carriers and other logistics providers.

Companies need to take care to explain the concept of integrated systems to regulators. Hutchinson recommends including the information in a validation master plan. "It's a hard concept to get your head around, without having written it down in a detailed format," he says.

Regulators have been asking shippers how they protect their cold chains for some time now. Only recently, however, have companies begun applying basic validation principles to cold-chain system management.

"Cold-chain management and your [accompanying] transportation processes can be validated like any other processes," notes Hutchinson. "Following regulatory body guidelines, and applying them to cold-chain management systems, is a great place to start."

Only recently have regulators begun issuing guidance for good distribution practices, says Hutchinson. It is therefore the job of industry and trade associations to pick up the slack.

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Keywords: supply chain, supply chain management, inventory control, transportation management, logistics management, warehouse management, WMS warehouse management, cold chain logistics, pharmaceutical supply chain, biotech supply chain