Sharp, a provider of pharmaceutical packaging and clinical services and part of UDG Healthcare, has reached a milestone in its track and trace program by equipping its 50th line with serialization capabilities ahead of the U.S. and European regulatory deadlines in 2018/19 aimed at preventing counterfeit product from entering the supply chain.
The 50th line, located at the Allentown facility in Pennsylvania, marks the latest milestone in Sharp’s ongoing serialization program to meet new the legislative requirements in the U.S. and Europe. Having started serializing products over nine years ago, the company currently runs more than 70 serialization projects, supplying products across the globe, supporting eight international serialization programs.
Rick Seibert, Senior Vice President of Global Innovation & Technology Service at Sharp said: “Many industry players have underestimated the impact that implementing serialization can have on an organization and have delayed their preparations for the Drug Supply Chain Security Act (DSCSA) and the EU Falsified Medicines Directive (EU FMD), meaning they are underprepared and unlikely to be fully compliant in time for the deadlines.
The company’s first serialization project for Cephalon began in 2008 ahead of the Californian e-Pedigree deadline in January 2009. Sharp were responsible for validating and packaging several products for the biopharmaceutical company from its Allentown facility.
“At the time that we approached Sharp we were exploring how packaging technology could allow us track product through the supply chain,” Gerry Frank, former Senior Director of Packaging Technology at Cephalon said. “Sharp’s expertise and innovative approach to serialization was invaluable throughout the project.”