Executive Briefings

New Rules for Bio and Pharma Industries: A Briefing

Mike Cleland, vice president of NorthHighland, discusses what biotech and pharma companies need to do to comply with new regulations for tracking products throughout the supply chain.

Common part numbering is a means of achieving process standardization by biotechnology and pharmaceutical companies across multiple supply chains, from manufacturing through consumption. E-pedigree, another new industry requirement, was devised to stop counterfeiting in the pharmacy trade, although it has proved to be of additional value as a means of tracking the ownership of a drug throughout its life.

Cleland counters the notion that the two concepts are simply being forced on the industry. Those who embrace them can realize additional efficiencies in their supply chains. "If you're responding simply as a compliance initiative," he says, "then you aren't driving value out of it." For example, biotech companies need to understand the many environmental factors that can affect a shipment, especially one that requires a consistent cold chain. Strict monitoring of product can detect degradations of the drug that might otherwise impact patient safety.

Recently, says Cleland, companies have begun to realize the business benefits of standardization and improved monitoring of product throughout the supply chain. A delay in the implementation of the e-pedigree requirements allowed regulators and the industry to come to common agreement on the details of the effort. In the process, the private sector began to understand how the initiative could be of benefit to it. E-pedigree, Cleland says, allows companies to isolate problems in specific product lots, instead of having to recall everything. "You establish not only the ownership," he says, "but the ability to respond."

Brand protection and reputation are paramount, Cleland says. They're a concern for all industries, but are  especially critical in the world of pharmaceuticals and biotechnology, where there's a need "for process alignment throughout the chain."

At first, it was all about compliance. "Now people are finding out that they can expand and improve value in the [supply] chain as well as in patient safety," Cleland says. "Process alignment is what's driving the value. And technology is emerging to support those process changes."

To view video in its entirely, click here


Keywords: supply chain, supply chain management, global logistics, supply chain planning, supply chain services, sourcing solutions, supply chain risk management, biotechnology supply chain, pharma supply chain, common part numbering, e-pedigree

 

Common part numbering is a means of achieving process standardization by biotechnology and pharmaceutical companies across multiple supply chains, from manufacturing through consumption. E-pedigree, another new industry requirement, was devised to stop counterfeiting in the pharmacy trade, although it has proved to be of additional value as a means of tracking the ownership of a drug throughout its life.

Cleland counters the notion that the two concepts are simply being forced on the industry. Those who embrace them can realize additional efficiencies in their supply chains. "If you're responding simply as a compliance initiative," he says, "then you aren't driving value out of it." For example, biotech companies need to understand the many environmental factors that can affect a shipment, especially one that requires a consistent cold chain. Strict monitoring of product can detect degradations of the drug that might otherwise impact patient safety.

Recently, says Cleland, companies have begun to realize the business benefits of standardization and improved monitoring of product throughout the supply chain. A delay in the implementation of the e-pedigree requirements allowed regulators and the industry to come to common agreement on the details of the effort. In the process, the private sector began to understand how the initiative could be of benefit to it. E-pedigree, Cleland says, allows companies to isolate problems in specific product lots, instead of having to recall everything. "You establish not only the ownership," he says, "but the ability to respond."

Brand protection and reputation are paramount, Cleland says. They're a concern for all industries, but are  especially critical in the world of pharmaceuticals and biotechnology, where there's a need "for process alignment throughout the chain."

At first, it was all about compliance. "Now people are finding out that they can expand and improve value in the [supply] chain as well as in patient safety," Cleland says. "Process alignment is what's driving the value. And technology is emerging to support those process changes."

To view video in its entirely, click here


Keywords: supply chain, supply chain management, global logistics, supply chain planning, supply chain services, sourcing solutions, supply chain risk management, biotechnology supply chain, pharma supply chain, common part numbering, e-pedigree