Manufacturers and contract packagers may miss serialisation deadlines, claims research


New industry research carried out by serialisation system provider SEA Vision and life science technology firm Zenith Technologies has claimed that nearly 36% of pharmaceutical manufacturers and contract packagers are not preparing for global serialisation requirements in spite of impending deadlines.

The research emphasises on an immediate need for the companies to focus on fulfilling the demands of the US Drug Supply Chain Security Act (DSCSA) and the European Falsified Medicines Directive (FMD).

Approximately 51% of the companies within the research stated that they do not have adequate resources to carry out the serialisation process while 15% attributed it is too early to start the preparations.

SEA Vision US serialisation director Carlos Machado 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 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."

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

The research also found that 56% have initiated the serialisation process, of which just 44% has planned to utilise it to achieve wider business benefits.

Carlos added: “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.”

Last year, SEA Vision and Zenith Technologies entered a global partnership to provide assistance to the pharmaceutical companies in installing and integrating the serialisation process within their drug manufacturing sites.

The partnership leverages on SEA Vision’s serialisation system with Zenith Technologies’ expertise to integrate systems and provide companies with necessary technical support.