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  1. Zenith Technologies
5 September 2017

Manufacturers and Contract Packagers May Miss Serialisation Deadlines

Industry research conducted in May this year revealed that more than one third (36%) of pharmaceutical manufacturers and contract packagers were not preparing for global serialisation requirements, despite impending deadlines.

Conducted by serialisation system provider SEA Vision and life science technology firm Zenith Technologies, the research 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 do not currently have enough internal resources to devote to serialisation, while 15% believe it is too early to begin preparations.

Commenting on the research, serialisation director at SEA Vision US Carlos Machado said: "Our research has confirmed that many companies are under-estimating 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: "While 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 serialization 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.

The life science industry has a strong legacy in data collection and has been embracing Industry 4.0 methodology before the term existed.
The biopharma industry has experienced rapid expansion over the last three decades.
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