Regulatory compliance standardsNew industry research reveals that more than one third (36%) of pharmaceutical manufacturers and contract packagers are not currently preparing for global serialisation requirements, despite impending deadlines.

The research, conducted by serialisation system provider SEA Vision and life science technology firm Zenith Technologies, highlights an urgent need for companies to turn their attention to meeting the demands of the US Drug Supply Chain Security Act (DSCSA) and the European Falsified Medicines Directive (FMD).

Out of those companies that are not preparing for the new regulations, around half (51%) say it is because they don’t currently have enough internal resource to devote to serialisation, while 15% believe it is too early to begin preparations.

Commenting on the research, Carlos Machado, Serialisation Director at SEA Vision US, said: “Our research has confirmed that many companies are underestimating the enormity of the task at hand. Preparing for serialisation is a complex process that is so much more than simply integrating new technology on a packaging line. Instead, it should be a company wide initiative, involving all corners of an organisation and the wider pharmaceutical supply chain.”

“Those companies that delay their preparations risk production downtime and loss of business in key markets.”

For 56% of those that have begun their serialisation journey, compliance is the only goal of their serialisation project at this stage. Just 44% intend to use the process to achieve wider business benefits.

Carlos continued: “Although serialisation presents a number of challenges, it also creates an opportunity to review business processes and improve productivity. Those companies that embrace the changes and make preparing for the DSCSA and the FMD a priority, have a real opportunity to differentiate their offering, and it is our goal to support this process.”

In 2016, SEA Vision and Zenith Technologies formed a global partnership to support pharmaceutical companies with the impending challenge of installing and integrating serialisation across drug manufacturing sites.

The collaboration brings together Italian-based SEA Vision’s serialisation system along with global Zenith Technologies’ ability to integrate systems and deliver ongoing technical support at a local level.