Major doubts revealed about requirements for serialization!

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.

Download e-book

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 SEA Vision and  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 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 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.

@SEA_Vision  @ZenithIre  #PAuto 

Dangerous underestimation of urgency in meeting drug regulations.

New industry research reveals that more than one third (36 per cent) of pharmaceutical manufacturers and contract packagers are not currently preparing for global serialization requirements, despite impending deadlines.

The research, conducted by serialization system provider SEA Vision and life science technology firm Zenith Technologies, highlights an urgent need for companies to turn their attention to meeting the demands of the US Drug Supply Chain Security Act (DSCSA) and the European Falsified Medicines Directive (FMD).

Out of those companies that are not preparing for the new regulations, around half (51 per cent) say it is because they don’t currently have enough internal resource to devote to serialization, while 15 per cent believe it is too early to begin preparations.

Commenting on the research, Carlos Machado, serialization director at SEA Vision US, said: “Our research has confirmed that many companies are under-estimating the enormity of the task at hand. 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 organisation and the wider pharmaceutical supply chain.

“Those companies that delay their preparations risk production downtime and loss of business in key markets.”

For 56 per cent of those that have begun their serialization journey, compliance is the only goal of their serialization project at this stage. Just 44 per cent intend to use the process to achieve wider business benefits.

Carlos continued: “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.”

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.

@SEA_Vision  @ZenithIre  #PAuto #Pharma

Serialisation research survey!

"What is the biggest challenge you face when preparing for pharmaceutical serialisation? Are you clear what the global requirements for serialization are?" asks Zenith Technologies.

Zenith along with with SEA Vision is conducting some serialisation research to better understand users' views.

Participants in this short serialisation research survey will gain exclusive access to a free e-book with tips and guidance to prepare for new serialisation regulations, while also helping to significant business improvements.

Participation in serialization research will ensure receiving a summary of the findings (though responses will of course remain anonymous).

 @ZenithIre  #PAuto @SEA_Vision

Serialisation director for US project support.

Carlos Machado has been appointed by Zenith Technologies as serialization director to lead the company’s sales, operations, implementation and post project support services in the US.

Carlos Machado

The appointment comes as the pharmaceutical industry faces the challenge of complying with new legal requirements for the authentication and barcoding of licensed drug products from November 2017 in the US and early 2019 in Europe.

Carlos joins Zenith Technologies with significant experience of assisting pharmaceutical manufacturers with track and trace technologies, having worked on more than 75 serialization projects from both an operations and delivery perspective.

In his former role as director of global operations at a leading anti-counterfeiting technology provider, Carlos helped to pioneer the serialization concept and define the future of authentication.

Jim Lehane, director at Zenith Technologies, said: “Serialization is a real challenge for our customers and it’s an important time for us to add further expertise to our team. Carlos’ background in track and trace technologies and his knowledge of the implementation challenges pharmaceutical manufacturers face, make him ideally suited to lead our serialization offering in the US, helping our customers achieve seamless compliance with the new regulations.

“Zenith Technologies has strong partnerships with many of the world’s largest pharmaceutical manufacturers as well as life science companies of all sizes, providing automation consulting and local support services. Carlos’ appointment will help us to take our US offering to the next level.”

Commenting on his appointment, Carlos said: “Serialization is a huge priority for Zenith Technologies as we understand the challenges customers face in addressing supply chain security and preventing the introduction and distribution of counterfeit product into the global marketplace. It is an exciting time to join the firm as we expand our US presence, leveraging our technological experience, sound project management practices, skilled engineers and world-class implementation and support services.

“When it comes to complying with new serialization regulations, the industry, ranging from the top pharmaceutical companies to contract manufacturing organizations (CMOs), understands what needs to be done. The challenge lies in the scale and complexity of the task ahead. In my new position, it is my responsibility to draw on my industry experience and work alongside our customers to simplify the implementation process and provide flawless execution.”

The announcement is the next stage in Zenith Technologies’ goal to assist companies in the US and Europe with the challenge of serialization. The company recently announced a global partnership with software provider SEA Vision to support pharmaceutical companies with the installation and integration of serialization solutions across drug manufacturing sites.

Carlos continued: “Given our combined expertise and remarkable track record, it’s a natural marriage. We will be working exclusively with SEA Vision to improve existing processes and delivery time, implement its technology and systems and enhance the overall customer experience.

“Our organizations are also working towards providing an innovative interactive e-learning environment to assist our customers with serialization training. We are also actively recruiting and adding experienced talent to our serialization taskforce in the US to ensure we can continue to deliver a high level of service at a local level.”

Marco Baietti, commercial director at SEA Vision said: “Carlos provides a unique combination of leadership skills and expertise in the serialization field thanks to his specialist background. We are thrilled to welcome him to the team and look forward to working together to deliver our shared goal to provide the best track & trace solutions and services in the markets that we serve.”

With its US headquarters in Pennsylvania and 14 offices globally, Zenith Technologies is one of the leading companies in delivering full life cycle enterprise, manufacturing and operational support solutions that enable life science businesses to be compliant and competitive.

#PAuto @ZenithIre