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With the fairly recent DQSA (Drug Quality and Security Act), plus new regulations in China for GSP, and the EU for GDP, plus rumors that Japan will be adopting the EU GDP guidelines, it seems that global regulations are becoming harmonized. These regulations are based upon quality, risk mitigation, and the measures taken to prevent adulteration or the counterfeiting of drugs.

Many guidelines are in place for messaging up and down the supply chain with "global' formats for e-Pedigrees. There are even checks on who takes ownership and resells to what state or to the next level down the chain. What might be missing here is the element of quality and efficacy when it comes to biologics, vaccines, and temperature controlled products (This is the temperature condition of the product on shipment, during transit, and upon receipt) linked in with the other anti-adulteration risk mitigation components.

This may be early in the dawn of a new era of drug security, but it will take many years to fully implement totally compliant solutions. And yet, the cold chain logistics channels’ risk aversion strategies are by and large already in place for most of the major drug companies.

Food for thought: Wouldn't now be a good time to think about integrated solutions combining the cold chain with the anti-counterfeiting solutions so a consolidated approach can be implemented sooner, rather than later?

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Peter Norton is a senior logistics and supply chain manager and consultant to the life science industry, with extensive experience in both the domestic US and global markets.

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