Recipharm Launches Serialization Line
Recipharm, a contract development and manufacturing organization, has launched a showcase line for serialization offering pharmaceutical companies the chance to view and trial its solution to the new European Union Falsified Medicines Directive (EUFMD) Safety Features Delegated Regulation, which makes the serialization of licensed drug products in Europe a legal requirement from 2019, and the new US Drug Supply Chain Security Act (DSCSA), in which serialization will be enforced starting in November 2017.
The showcase line at Recipharm’s Fontaine, France, site is now operational. The showcase line will perform activities, including the downloading of serial numbers from a Level 4 solution, serialization of the package, and the application of tamper-evidence labels. It will also demonstrate manual aggregation, including labeling of boxes and pallets and post-serializations work, including the reworking and uploading of data to Level 4.
Recipharm’s new line is the latest step in a EUR 40 million ($45 million) project to implement a solution for its customers’ serializations requirements across its 75 production lines in Europe. The project will be carried out over the next three years.
As part of the serializations roll-out, Recipharm has developed a pricing model that spreads the cost of the process across each customer’s ongoing supply agreement. From early 2017 Recipharm will offer the service free of charge until it becomes a legal requirement.