More than one third of pharmaceutical industry professionals are not confident that they will meet serialization deadlines in the US and Europe, according to new industry research.
As the FDA has announced plans to delay the active enforcement of the Drug Supply Chain Security Act (DSCSA) in the US to November 2018, the research, conducted by serialization system provider SEA Vision and life science technology specialist Zenith Technologies, gives further evidence for the need for additional time both in the US and Europe.
Just 18 percent of those that took part in the survey are “extremely confident” that they will meet impending track and trace deadlines, including the US DSCSA and the European Falsified Medicines Directive (FMD).
Highlighting a major cause of the lack of preparedness, 40 percent of industry professionals admit that they are not clear what the global requirements for serialization are.
Despite the lack of understanding, the majority of companies will rely on an in-house team to handle the entire implementation. One third will use an implementation partner and 20 percent will rely on their software and hardware providers for the required support and expertise.
“Clearly the industry is going through a challenging period and there is nervousness around whether the supply chain will be ready for compliance deadlines in the US and Europe,” Carlos Machado, serialization director at SEA Vision US, said. “The delay of the active enforcement of the DSCSA should not be viewed as a reason to be complacent, but instead the chance for small and mid-sized manufacturers that are behind in their serialization journey to get their preparations back on track.”
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 serialization system along with global Zenith Technologies’ ability to integrate systems and deliver ongoing technical support at a local level.