Sharp, a global provider of pharmaceutical packaging and clinical services, part of UDG Healthcare, has reached a milestone in its track and trace programme by equipping its fiftieth line with serialisation capabilities ahead of the US and European regulatory deadlines in 2018/19 aimed at preventing counterfeit product from entering the supply chain
The fiftieth line, located at the Allentown facility in Pennsylvania, marks the latest milestone in Sharp’s ongoing serialisation programme to meet the new legislative requirements in the US and Europe.
Having started serialising products more than 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 VP 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 (EFMD), 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 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 was 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 is fascinating to see how the pharmaceutical industry is adopting serialisation programmes as we face the regulation deadlines globally.”
Sharp will exhibit at CPhI WW 2017, for further information please visit the stand 41B32.