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A recent survey suggests that 36% of pharmaceutical companies and contract development and manufacturing companies have not started working on serialization, and that those who are working on it are focusing on basic compliance rather than potential long-term business benefits.
Although deadlines for serialization are only a few months away, a recent survey suggests that 36% of pharmaceutical manufacturers and contract packagers are not preparing to meet global serialization requirements. This latest research, by the serialization system provider SEA Vision and the life sciences technology company Zenith Technologies, suggests an urgent need for companies to focus on meeting requirements set by the US Drug Supply Chain Security Act (DSCSA) and the European Falsified Medicines Directive (FMD).
Roughly half (51%) of respondents to the survey whose companies are not preparing to meet the regulations attribute that to lack of internal resources. However, another 15% of respondents believe it is “too early” to begin preparations.
Many companies are underestimating the enormity of the task at hand, says Carlos Machado, serialization director at SEA Vision US. “Preparing for serialization 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 organization and the wider pharmaceutical supply chain,” he says. “Those companies that delay their preparations risk production downtime and loss of business in key markets.”
Another problem that the research found is lack of understanding of the potential long-term benefits of serialization, which can improve supply chain efficiency. For 56% of respondents to the survey that have begun their serialization journey, compliance is the only goal; only 44% of respondents say they intend to use serialization to achieve broader business benefits.
“While serialization 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,” says Machado.
SEA Vision and Zenith formed a partnership in 2016, designed to support pharmaceutical companies in installing and integrating serialization across their manufacturing sites.
An archived version of the May 2 webcast, “Serialization for Late Starters,” is available, during which Mr. Machado and SEA Vision’s product manager Paolo Landriani discuss insights from the survey, and approaches that companies can take to serialization, even at this late stage.