More than one third (40 per cent) 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 per cent of those that took part in the survey are ‘extremely confident’ that they will meet serialization deadlines, including the US DSCSA and the European Falsified Medicines Directive (FMD).
Highlighting a major cause of the lack of preparedness, 40 per cent of industry professionals admit that they are not clear what the global requirements for serialization are.
Despite the lack of understanding, the majority (38%) of companies will rely on an in-house team to handle the entire implementation. One third will use an implementation partner and 20 per cent will rely on their software and hardware providers for the required support and expertise.
Commenting on the research findings, Carlos Machado, serialization director at SEA Vision US, said: “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.
“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.
“Just 43 per cent of those companies surveyed are already supplying serialized products to other markets where regulations are in place, so for many, the DSCSA and the FMD are steps into the unknown. As a result, we believe that reliance on implementation partners will increase and this brings about new challenges as demand may surpass capacity as the deadlines draw closer.”
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, enabling them to meet serialization deadlines.
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.