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Proposed standard offers best practices to help ensure pharmaceutical supply chain integrity
Date:1/4/2012

t on hot-button issues such as track and trace technology and, at the larger level, to codify what constitutes a solid, universal approach to global supply chain integrity," said Praveen Tyle, Ph.D., chief science officer for USP. "USP has developed an initial proposal that we expect to evolve as industry, FDA and others weigh in. Our role as an independent body provides an opportunity to convene all these parties and advance this critical issue. While some pockets of information are available via FDA guidances, trade organizations and other sources, an overall approach is lacking. USP can move forward something more concrete than a technical report, as part of a mechanism that can be regularly updated to best meet the needs of all."

The proposed standard covers four main areas:

  • ImportationDetails three primary initiatives importers should undertake to help prevent and detect potential risks: supply chain risk management, development of effective supplier partnerships and building a supply chain quality system.
  • Counterfeit Drugs and Medical DevicesDocuments types of counterfeit drugs, medical consequences, and distribution and extent of counterfeit drugs and devices.
  • Best Practices to Combat Counterfeit Drug and Medical DevicesCovers topics including packaging technologies (tamper-evident designs, authentication technologies and serialization); drug pedigrees; machine-readable data carriers (2D bar codes and RFID tags); repackaging guidance, information retention and security; international standards; and best anti-counterfeiting practices.
  • Diversion and TheftAddresses factors that raise the risk of theft of drug products, drug components and medical devices; security systems, devices and procedures that should be implemented to reduce risk; and critical information to be gathered following discovery of a theft.

USP is a nonprofit public health organization that develops standards for the identity, strength, qu
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Contact: Francine Pierson
fp@usp.org
301-816-8588
US Pharmacopeia
Source:Eurekalert

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