Partners with Marchesini, SEA Vision and TraceLink
Recipharm, the contract development and manufacturing organisation (CDMO), has formed a global partnership with Marchesini, SEA Vision and TraceLink to introduce new serialisation capabilities. The announcement marks the next step in the global CDMO’s plans to invest €40m over the next three years to ensure state-of-the-art solutions for serialisation processes.
The investment will ensure that pharmaceutical companies accessing Recipharm’s manufacturing services will comply with the EU Falsified Medicines Directive (EUFMD) Safety Features Delegated Regulation, which makes serialisation of licensed drug products in Europe a legal requirement from early 2019.
After assessing various vendors, Recipharm selected Italian-based Marchesini and SEA Vision to meet its hardware and software requirements for serialisation at levels one (device level), two (line level) and three (site level). The company has also selected the TraceLink Life Sciences Cloud, the world’s largest pharma track and trace network, which will act as a level 4 central repository to meet the CDMO’s enterprise serialisation management and global tracking needs.
The complete serialisation solution will be implemented in 15 of Recipharm’s European locations and on more than 70 production lines. The company anticipates that a pilot showcase line will be operational from July 2016 to allow customers to view and trial Recipharm’s standard solution for serialisation and aggregation.
EP News Bureau – Mumbai