Sharp, a global provider of pharmaceutical packaging and clinical services and part of UDG Healthcare, has reached a milestone in its track and trace programme by equipping its 50^th line with serialisation capabilities ahead of the U.S. and European regulatory deadlines in 2018/19 aimed at preventing counterfeit product from entering the supply chain.
The 50^th line, located at the Allentown facility in Pennsylvania, marks the latest milestone in Sharp’s ongoing serialisation programme to meet new the legislative requirements in the U.S. and Europe. Having started serialising products over nine years ago, the company currently runs more than 70 serialisation projects, supplying products across the globe, supporting eight international serialisation programmes.
Rick Seibert, Senior Vice President of Global Innovation & Technology Service at Sharp said: “Many industry players have underestimated the impact that implementing serialisation can have on an organisation 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.
“Serialisation is not a new concept. Sharp has been serialising products for almost a decade meaning we have a team of industry leaders with considerable expertise and depth of knowledge in this area.
“As a result, we can offer our customers a scalable and accelerated onboarding process, making their journey to compliance more streamlined and less time and cost intensive. We expect to see many companies, particularly small and mid-sized players, relying on outsourced packaging solutions in order to maintain continuity of supply post-enforcement dates.”
The company’s first serialisation 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.
Gerry Frank, former Senior Director of Packaging Technology at Cephalon said: “At the time that we approached Sharp we were exploring how packaging technology could allow us track product through the supply chain. Sharp’s expertise and innovative approach to serialisation was invaluable throughout the project.
“Now, nine years later, it’s fascinating to see how the pharmaceutical industry is adopting serialisation programs as we face the regulation deadlines globally.”