April 4th, 2012 
Rockville, Md. (PRWEB) January 04, 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 here.
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 Good Distribution Practices?Supply 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 industry?large and small companies, regulators and standards-setting bodies?to come to some agreement 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:
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