USP suits up for pedigree challenge

The U.S. Pharmacopeial Convention (USP) is grabbing the pedigree hydra by the tail, launching its own initiative for end-to-end supply-chain tracking and security. Its proposal acknowledges both the many and varied factions populating the drug supply chain and their likely differences in technical capability.

"There are some big differences when you start talking about best practices," says Desmond Hunt, senior scientific liaison, in a phone interview. Those differences might be found, for example, in something as simple as supplier auditing. Big Pharma companies have sophisticated auditing programs, he says, while raw materials suppliers and smaller logistics providers might not. "How do you get them up to speed?" Hunt asks.

The USP proposal takes the form of a new general chapter, <1083> "Good Distribution Practices—Supply Chain Integrity," to appear in this spring's Pharmacopeial Forum (PF) 38(2). The chapter will complement existing chapter <1079> "Good Storage and Shipping Practices."

USP breaks the pedigree proposal into four parts, according to an announcement: importation, counterfeiting, combating fakes, and diversion and theft. "These are the four areas that kept coming up in discussions," Hunt says; the "hottest topics." The scheme contrasts with some pedigree proposals, which follow a more sequential organization: raw material supplier, manufacturer, distributor, etc.

Because the pedigree standard will have a broader impact than the many chapters specific to drug manufacturing, USP is trying to broaden the universe of contributors, says Anthony DeStefano, VP for general chapters, in the same interview. To do so, it's hosting a workshop as part of the standard-development process, in hopes the workshop will attract contributors outside "the normal Pharmacopeial folks," DeStefano says.

The proposed guidelines are "not mandatory," the release continues, though the document will ultimately be a standard. It is intended as central guidance, "outlining the essential elements of an effective strategy."

- read the release
- here's the proposed new chapter

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