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The Global Supply Chain and Value-Add to Serialization Compliance

According to Dave Ulrich, QA Director of SC Compliance at Abbvie, “The future is here, whether we like it or not.”

Cold Chain Council 2019
Cold Chain Council 2019

Speaking to the Cold Chain Council in Chicago in early October, Ulrich talked global serialization, how to secure a global supply chain, and how to add value beyond compliance. He said that while a pharmaceutical manufacturer may think they are “done” with a product after it is produced, counterfeits and diversion exist, so companies must consider how to safely get the product from manufacturing facility to the patient.

“How do you know you’re making and distributing a good product?” asks Ulrich. He goes on to say that the biggest consideration right now is the Drug Supply Chain Security Act (DSCSA), and in the EU, the Falsified Medicines Directive (FMD), and they are both part of government’s Good Distribution Practices (GDP) program. These directives include temperature management, info compliance and serialization, among other good business practices.

“GDP’s are the core competencies of temperature management,” said Ulrich, “Ship it right, deliver it right, maintain it right.” Other GDP’s include serialization, importation control, supplier control, and controlling internet sales where counterfeit, stolen or diverted product may be sold. EU Safety Features (and all government regulations are heading this way, according to Ulrich) include a 2D matrix barcode which make the sale of a unit unique. By 2023, said Ulrich, the consumer should be able to track the lot, expiration date serialization number, etc. of the drug they purchase, and the serialization number should not be able to be used again, which should tighten up the supply chain. “It’s the right saleable unit that’s not been adulterated.”

According to Ulrich, the wholesaler or consumer needs to know: “What did you buy? Is it the right thing, the right quality?” And the manufacturer needs to know: “Can you put it away, can you find it, ship it and move it where it needs to be?”

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