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Cold Chain Forum takes global, holistic perspective

Among the event’s highlights is a new U.S. Pharmaceopeia 1083 guidance chapter aimed at pharmaceutical counterfeiting in the supply chain.

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In the not-too-distant future, it could well be that a nurse or medical care practitioner will scan a package and verify that it is the right product and that it has not been tampered with and is not counterfeit.

That’s a prediction from Geoffrey Glauser, Biomedical Advanced Research and Development Authority, U.S. Department of Health & Human Services at the 9th Annual Cold Chain & Temperature Management Global Forum Sept. 28 in Philadelphia.

He said, “Track and trace is going to become much more significant throughout the entire supply chain, especially with California demanding product pedigrees for pharmaceuticals in the 2015-2017 time frame.” At some point, Glauser noted, every unit of sale will require serialization, a product identification to help prevent counterfeiting. A database could include every product from every manufacturer. “There are implementation programs in Brazil, Turkey, and Argentina, with pilot programs in Sweden and Germany. This is on the horizon, and it’s coming,” he said.

New 1083 chapter

Dr. Mary Foster, chair, packaging and storage expert committee with the U.S. Pharmacopeia, and vp with Aphena Pharma Solutions, noted that a new chapter in the 1083 guidance has “the ultimate goal to prevent adulterated and misbranded materials from entering the supply chain and to detect counterfeiting or diversion.

“The new 1083 chapter is similar to 1079 except that it includes active pharma ingredients and excipients, packaging components, and medical devices,” she said, “It takes in the whole picture of the movement of a drug. We need industry and subject matter expertise and feedback. It’s a guidance document, not a mandatory one as are chapters numbered under 1,000. This is a brand new chapter, and you are the first people to see it.”

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