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Standards Proposed for Pharmaceutical Supply Chain Integrity

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The U.S. Pharmacopeial Convention (USP) is proposing a set of recommended best practices to help ensure supply chain integrity, and reduce the risks of counterfeit or mishandled medicines. USP released the draft standards for comment in advance of a workshop on supply chain integrity at its headquarters in Rockville, Maryland on 22-23 May 2012.

Supply chain integrity involves minimizing risks from the sources of pharmaceutical raw materials to their manufacture and distribution. USP developed the standards as a guidance document offering the elements of an effective strategy. USP notes that the size and sophistication of companies in the industry and their suppliers vary, as do their quality systems and risk management approaches. Likewise, there is no broad industry consensus on track-and-trace technology, and smaller companies may not have adequate security systems comparable to those used by larger companies.

The proposed standards cover four topics:

– Importation, with measures for importers addressing supply chain risk management, development of effective supplier partnerships and building a supply chain quality system.

– Counterfeit drugs and medical devices, that documents types of counterfeit drugs, medical consequences, and distribution and extent of counterfeit drugs and devices

– Best practices to combat counterfeit drug and medical devices, that include packaging technologies, drug pedigrees, machine-readable bar codes and RFID tags, and guidance on repackaging such as information retention and security

– Diversion and theft, addressing factors that raise the risk of theft of drug products and medical devices, security systems and procedures that should be implemented to reduce risk, and critical information to be gathered following discovery of a theft.

USP says the standards should be helpful to manufacturers and suppliers, as well as transportation companies, logistics services, importers and exporters, mail-order pharmacies, retail pharmacies, point-of-care clinics, and hospitals. The formal document will be published in the March-April 2012 issue of Pharmacopeial Forum.

Read more: Database to Track Substandard, Counterfeit Medicines

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