According to new industry research by SEA Vision and Zenith Technologies, more than half (54%) of industry professionals believe that the cost of implementing serialisation is the greatest hurdle to compliance
The research, conducted by serialisation software provider, SEA Vision and life sciences technology firm, Zenith Technologies, highlighted that the substantial investment required to implement a serialisation solution is cause for concern ahead of regulatory deadlines in the US and Europe.
A further 33% of survey respondents stated the implementation process would be a drain on internal resource.
Others (31%) cited tight timescales as a pain point, a statistic that is further supported by the announcement that the FDA will delay the active enforcement of the Drug Supply Chain and Security Act (DSCSA), due to a lack of readiness across the industry.
Carlos Machado, Serialisation Director at SEA Vision US, said: “The new regulations in the EU and the US represent a substantial upfront investment for companies across the supply chain and many smaller players are struggling to implement a suitable process as a result.
“The resource required in terms of cost and manpower is a notable barrier to compliance, but added to that the time it takes to develop a solution has been gravely underestimated by a large part of the industry. Many (37%) of our survey respondents expressed concerns surrounding the potential disruption to product supply as a result of technical issues and downtime, which clearly demonstrates the impact serialisation could have at an operational level.
Consolidation across the outsourcing space has been prevalent for some time now and serialisation is undoubtedly driving smaller companies to consider partnerships to offset a lack of manpower and budget.
However, 36% also believed that there was a knowledge gap in their existing teams surrounding serialisation, making external expertise vital to ensuring compliance.
Machado continued: “With time and cost becoming a growing concern across the pharmaceutical industry, it is no surprise that smaller partners, particularly contract manufacturers are looking to consolidate to expand their internal resource.
“In addition to consolidation and a growing trend to outsource serialisation requirements, it is also likely that we will see an increased reliance on third party implementation specialists with the knowledge and expertise to effectively introduce the necessary changes and also help companies realise the wider business benefits that can be achieved. For example, implementing serialisation can also help to improve line performance and overall equipment effectiveness (OEE).”
In 2016, SEA Vision and Zenith Technologies formed a global partnership to support pharmaceutical companies with the impending challenge of installing and integrating serialisation 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.
For more information on how to overcome the challenges of serialisation and what steps to take, a free eBook can be downloaded at http://www.seavision.it/category/e-books/