According to new industry research more than half (54 per cent) of industry professionals believe that the cost of implementing serialization is the greatest hurdle to compliance.
The research, conducted by serialization software provider, SEA Vision and life sciences technology firm, Zenith Technologies, highlighted that the substantial investment required to implement a serialization solution is cause for concern ahead of regulatory deadlines in the US and Europe.
A further 33 per cent of survey respondents stated the implementation process would be a drain on internal resource. Others (31 per cent) 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.
Commenting on the research, Carlos Machado, serialization 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 per cent) 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 serialization could have at an operational level.
Consolidation across the outsourcing space has been prevalent for some time now and serialization is undoubtedly driving smaller companies to consider partnerships to offset a lack of manpower and budget. However, 36 per cent also believed that there was a knowledge gap in their existing teams surrounding serialization, making external expertise vital to ensuring compliance.
Machado continued: “With time and cost becoming a growing concern across the pharmaceutical industry, it’s 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 serialization 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 serialization 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 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.
Macallan Whisky picks Izon® Technology as part of a comprehensive anti-counterfeit solution
(De La Rue Authentication Solutions)
The Edrington Group, makers of world renowned The Macallan Highland Single Malt Scotch Whisky, faced a challenge when re-filled used
bottles, intact with labels, began appearing on shelves under their brand name. This posed a serious consumer safety, as well as a global
brand issue. For a solution, they turned to Authentication Solutions for the key overt component of a comprehensive solution.
Epson builds market awareness of authentic product through implementation of layered AC tech
(De La Rue Authentication Solutions)
Epson Latin America estimated that 20% of the product in the market was counterfeit and entering the supply chain through local distributors. The existing anti-counterfeiting ink technology was compromised. Epson developed a new strategy to target unauthorized distributors in key countries and build market awareness of authentic product.
The StellaGuard™ solution leverages the benefits of a barcode and connects it with a three-dimensional visual reference that provides instantaneous authentication with copy-detect protection. StellaGuard™ is a patented and elegant solution to protect your assets, enabling trusted stakeholders, including customers, to authenticate a product using common everyday smart devices.
The smartphone: a new tool to spot fake products
The development of new smartphone technologies offers brands the opportunity to fight counterfeiting more efficiently and drive competitive differentiation by turning their products into smart assets. This paper examines the process of placing the consumer as one of the key actors against illicit trade and creating new business intelligence capabilities for brands.
Pharma Security World 2018: "Anti-counterfeiting and Brand Safety"
March 20-21, 2018 - London, UK
Global Illicit Trade Summit 2018: Out of the shadows
March 22, 2018 - Kuala Lumpur
4XScience 2018 E2E Supply Chain Serialization Benchmark Workshop
March 27-28, 2018 - Brussels, Belgium
Robert Schuman Foundation conference: Smuggling, counterfeiting and the financing of terrorism – mobilising economic stakeholders
April 11, 2018 - Brussels, Belgium
April 17-19, 2018 - New York (NY), USA
4th Global Brand Protection EU Innovation Programme (GBPIP)
April 26-27, 2018 - London, UK
IACC 2018 Annual Spring Conference
May 16-18, 2018 - Seattle (WA), USA
May 29 - June 01, 2018 - Milan, Italy
Partnership for Safe Medicines 2018 Interchange
June 07, 2018 - Washington D.C., USA
June 25-27, 2018 - London, UK
September 2018 (dates tbc) - Switzerland
Rx-360 Global Life Science Supply Chain 2018 Conference: Driving Innovative Quality Strategies
September 25-26, 2018 - Miami (FL), USA
2018 A-CAPP Center Brand Protection Strategy Summit
October 02-03, 2018 - East Lansing (MI), USA
13th Security Document Summit (SDS)
October 17-18, 2018 - Beijing, China
Anti-Counterfeit & Currency Expo (ACCE)
November 06-08, 2018 - Las Vegas (NV), USA