By November 2017, pharmaceutical manufacturers in the U.S. will have to comply with the U.S. Drug Supply Chain Security Act (DSCSA). As the deadline for global serialization draws closer, it is apparent that some companies are under-prepared and are unlikely to achieve compliance in time.
The U.S. deadline will be closely followed by the introduction of the European Falsified Medicines Directive (FMD) in 2019. For companies that will be supplying drug products in Europe, there is still time to act to ensure a fully operational serialization solution is in place in sufficient time.
In a piece for Contract Pharma, Carlos Machado, serialization director at SEA Vision U.S., discusses some of the key learnings that companies should take from the U.S. as they prepare for the regulations in Europe and for global serialization. He also highlights Turkey as a best practice example of serialization in operation.
More than 40 countries across the world have guidelines for item-level pharmaceutical serialization and traceability. Some countries, including Turkey, already have regulations in place, while others including the EU and the U.S. are in the deployment stages. It is a complex environment to navigate with different requirements across geographies, but prioritizing serialization is business critical and preparing early is the key to success.
In the U.S., it is likely that only 70% of small contract manufacturing organizations (CMOs) and contract packaging organizations (CPOs) will be ready for the DSCSA requirements later this year. It is important that companies preparing for the FMD don’t make the same mistakes.
Carlos highlights some of the lessons that can be learned from companies who have faced challenges in implementing serialization in the U.S., including the importance of future-proofing your serialization set-up to save time and money in the long term.
You can read more about some of the lessons learned from global serialization here.