Consortium Seeks Global Effort to Secure Supply Chains
Rx-360 continues to share its news flashes on safety and quality issues within the global pharmaceutical industry. The international consortium officially launched this summer, and so far it has discussed the Danish Medicines Agency’s acceptance of third-party audit reports and summarized the U.S. FDA’s guidances on melamine contamination and on the use of physical-chemical identifiers.
In Rx-360‘s June 2009 newsletter, Lewis Kontnik, director, Amgen Brand Protection, writes about the European Commission (EC) (http://www.e-pages.dk/dods/131/13) proposal for a directive on Falsified Medicines. He reports that this fall the European Parliament and Council of Ministers will consider amending EC directive 2001/83/EC in order to increase controls in the areas of product characteristics/Good Manufacturing Practices, supply chain/Good Distribution Practices, and active pharmaceutical ingredients. STORY CONTINUES BELOW
“Requiring manufacturers to use anti-tamper, authentication safety/security technology features on medicines is one of the key proposals,” writes Kontnik. “Parallel trade and repackaging remains an area of discussion in the proposal. While it would place legal liability on repackagers for counterfeits entering the chain through their repackaging, manufacturers want tighter controls.” In the meantime, to promote the tightening of the supply chain, Rx-360 encourages manufacturers to follow best practices and existing standards, and the group monitors and reports on global supply chain conditions. Data sharing depends upon interaction with consortium members, so industry participation and input is welcomed. Rx-360 also focuses on supply chains that lead into pharmaceutical manufacturing and packaging operations, so the consortium is working to evaluate available technologies to prevent adulterated materials from reaching manufacturers. Packaging and labeling supplies, too, must be safeguarded so that legitimate materials are not stolen for criminal use. Working with research organizations, Rx-360 will evaluate new technologies that will help secure the supply chain. Finally, the consortium hopes to develop a shared auditing model. Pharmaceutical companies routinely audit their suppliers, and given the number of different audits that take place a year, those audits may only last a day or two. “Auditors really need more time to see the whole picture and learn more about a given supplier,” says Martin VanTrieste, vice president of operations quality for Amgen. Amgen and several other pharmaceutical companies founded the not-for-profit consortium for pharmaceutical and biotechnology companies and their suppliers. (For more details on Rx-360, click here: http://www.pmpnews.com/article/circling-wagons-against-supply-chain-threats.) “One comprehensive audit that could be shared by several pharmaceutical companies would not only yield more data on a supplier, but it would also be more efficient,” says VanTrieste.
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