Recipharm, the contract development and manufacturing organization (CDMO), has launched a showcase line for serialization, offering pharmaceutical companies the chance to view and trial its solution to the new European and U.S. regulations.
The CDMO’s showcase line at Recipharm in Fontaine, France, is now operational and ready to demonstrate the company’s new standard solution for serialization to customers. The showcase line will perform activities including the downloading of serial numbers from our Level 4 solution, serialization of the package and the application of tamper evidence labels. It will also demonstrate manual aggregation including labelling of boxes and pallets and post-serialization work, including the reworking and uploading of data to Level 4.
Recipharm’s new line is the latest step in a €40 million project to implement a state-of-the-art solution for its customers’ serialization requirements across its 75 production lines in Europe.
The project, which is being carried out over the next three years, will ensure that all pharmaceutical companies using Recipharm’s contract manufacturing services comply with the EU Falsified Medicines Directive (EUFMD) Safety Features Delegated Regulation, which makes the serialization of licensed drug products in Europe a legal requirement from 2019.
As part of the serialization roll-out, the CDMO has developed a unique pricing model which spreads the cost of the process across each customer’s ongoing supply agreement, removing the need to make any upfront investment.
From early 2017, Recipharm will offer the service free of charge until it becomes a legal requirement, allowing customers to overcome any challenges, determine their individual requirements and request any customization before the deadline passes.
The CDMO’s company-wide serialization project is being led by Staffan Widengren, director corporate projects at Recipharm. He said: “Having already provided serialized products in markets including Turkey, Korea and China we understand the complexity of implementing serialization processes across existing production lines, so we made the decision very early on to be proactive and get ready for the changes as soon as we could.
“Companies that delay their preparations face a high risk of disruption to their production when the changes come into effect in 2019. By introducing this showcase line so far in advance we’ll be able to overcome any hurdles prior to the deadline and make the transition to serialized products as seamless as possible for our customers.
“As part of our preparations we’ve listened to our customers’ concerns surrounding serialization, which is why we’ve introduced a unique pricing model to help improve the affordability of the process.”
The industry-wide serialization, aggregation, and verification directive is expected to improve traceability of drugs and help in the fight against counterfeit products entering the supply chain via the introduction of 2D barcodes on all saleable drug items and will ultimately improve patient safety.
Recipharm serves 250+ customers and expects 85 percent of its production to require serialization. The CDMO will also be ready for U.S. serialization from November 2017 in-line with the U.S. Drug Supply Chain Security Act (DSCSA).
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