Recipharm has upgraded a facility in Lisbon to handle serialization of medicine packs as it continues to prepare for regulatory deadlines in the US and Europe.
The contract manufacturer says the facility is the sixth to be equipped with serialization capabilities since it announced a €40m investment programme to make its plants ready to start supplying serialized medicines packs last year, and means the project is now around one-third complete.
In the US all licensed drug products must be serialized to comply with the US Drug Supply Chain Security Act (DSCSA), which saw its deadline extended from November of this year to November 2018, while in Europe the serialization of drug products will be a legal requirement in February 2019.
A number of surveys have suggested that contract manufacturers are not moving quickly enough to meet serialization deadlines, which is a concern for overall pharma industry readiness as it has been estimated that just 10 per cent of pharma manufacturers will be able to meet EU obligations – for example – on their own.
Recipharm has been determined to make sure it will be ready in time, as it estimates that as much as 85 per cent of its production will require serialization in the coming years.
“We introduced our serialisation programme to ensure a consistent roll-out of our standard solution, without the implementation process having a significant impact on production activities,” said Staffan Widengren, the company’s director of corporate projects.
“It’s important our solution works at a local level, as well as company-wide, and the central team that heads up the programme is tasked with making this happen.”
The next Recipharm site to be upgraded for serialization will be its facility in Brescia, which will supply serialized product to the US.