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

Rockville, Md., January 4, 2012 As the pharmaceutical industry continues to globalize, the challenges of securing complex supply chains and protecting patients from counterfeit medicines, as well as the consequences of lapses in security or proper handling, have mounted. In an effort to encourage comprehensive public standards across the pharmaceutical industry, the U.S. Pharmacopeial Convention (USP) is proposing a set of recommended best practices that will help ensure that medicines can be traced back to their original manufacturer, are not adulterated or counterfeited, and are transported to their intended destination with their quality intact. USP is seeking broad feedback on these recommendations on supply chain integrity, which are posted at www.usp.org/USPNF/notices/generalChapter1083.html.

Supply chain integrity involves minimizing risks that arise anywhere along the supply chain, from sourcing pharmaceutical raw materials to their manufacture and distribution. The new standard being proposed is not mandatory, and is contained in the proposed USP General Chapter <1083> Good Distribution PracticesSupply Chain Integrity. The proposal is intended to serve as a central guidance document outlining the essential elements of an effective strategy. While individual pharmaceutical companies have their own approaches to addressing this issue, the size and sophistication of companies and their suppliers vary widely, as do their quality systems and risk management approaches. Broad consensus around issues such as track-and-trace technology does not exist, and smaller companies that may be relied upon for sourcing pharmaceutical ingredients may or may not have security approaches comparable to their larger counterparts.

"There is incentive for all players in the pharmaceutical industrylarge and small companies, regulators and standards-setting bodiesto come to some agreemen
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Contact: Francine Pierson
fp@usp.org
301-816-8588
US Pharmacopeia
Source:Eurekalert

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