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Recipharm adds hardware, software, and cloud services for serialization compliance processes.
Recipharm, a contract development and manufacturing organization, announced on June 22, 2016, new serialization capabilities, the next step in the company’s plans to invest $44.6 million (€40 million) over the next three years for serialization 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 serialization of licensed drug products in Europe a legal requirement from early 2019.
Recipharm selected Marchesini and SEA Vision to meet its hardware and software requirements for serialization at levels 1 (device level), 2 (line level), and 3 (site level). The company has also selected the TraceLink Life Sciences Cloud track-and-trace network, which will act as a level 4 central repository for enterprise serialization management and global tracking needs.
The serialization solution will be implemented in 15 of Recipharm’s European locations and on more than 70 production lines. The company anticipates that a pilot line will be operational beginning in July 2016.
Recipharm serves more than 250 customers and expects 85% of its production to require serialization.