The Drug Quality and Security Act (DQSA) of 2013 may have reset the clock for pharmaceutical track and trace and serialization, but there’s little reason for manufacturers to pause. Despite the progress made by industry pioneers and pilot programs, there are still “tremendous unmet needs,” observes Tim Marsh.
Regardless of the regions in which your company markets pharmaceuticals, you are probably preparing for changes in product identification. A new U.S. federal law has preempted California’s electronic pedigree requirement, giving companies more time to implement new identification approaches for that market, but other requirements around the world are phasing in. And given the globalization of the pharmaceutical supply chain, drug manufacturers undoubtedly are looking beyond individual markets and searching for strategies to maximize technology investments.
“Introduction of counterfeit products in the normal international supply chain poses particular issues for pharmaceutical companies, both from direct risk to their customers and to their own reputation within what is a highly competitive industry,” cautions Charles A. Smith, senior systems consultant at Horizon. “There is a direct cost of product recall, where positive identification of counterfeits can be difficult, without the identification and data handling capabilities provided by serialization.”
Experts from Optel Vision and NJM Packaging spoke about preparing packaging lines for item-level serialization during an hour-long conference at Pack Expo Las Vegas on September 24. Jean-Pierre Allard from Optel Vision and Dan Lapierre from NJM Packaging discussed packaging line integration challenges and possible solutions.
The California State Board of Pharmacy will be holding an E-Pedigree Committee Meeting in El Segundo, CA, on September 26, 2013. The meeting is open to the public and it will also be broadcast via a Webcast.
The CA BoP reports it will address the following:
As drug manufacturers take steps to comply with serialization requirements around the globe, they may also be able to benefit from the significant amounts of data generated by serialization. So argued Peter Schmitt, managing associate of Montesino Associates LLC, who spoke on the opening day of Pharmapack North America in Philadelphia.