COMPLIANCE

Answers to the industry’s concerns regarding serialization compliance

JEAN-LUC LASNE Written by JEAN-LUC LASNE
01/12/2016

When planning for the implementation of a serialization solution there are many practical questions to take into account!

The latest IQPC report sheds light on the progress of the pharmaceutical industry in terms of serialization compliance and on the hurdles that still need to be overcome. While serialization projects look daunting, there are answers and solutions to make things go as smoothly as possible.

The current state of serialization compliance

More than forty different legislations with varying deadlines ranging from 2017 to ‘not defined yet’ are not the only concern for the pharmaceutical industry. Apart from the risks for patient safety, the necessity to be on time to avoid fines, the risk of losing market shares and stakeholders’ confidence, there are many practical questions to take into account when planning for the implementation of a serialization solution. The latest IQPC report lists some of them.

Complexities of serialization (beyond compliance):

  • Creation and management of unique serialization codes for individual products during the production process and their company-wide coordination
  • Seamless integration with existing technologies, enterprise systems and third parties i.e. CMOs, 3PLs and CFAs
  • Integration of different coding formats and related costs
  • Deadlines

 

Timing is everything

25% of companies participating in the report say they have advanced little to not at all in their serialization planning strategy which is, quite frankly, astonishing. Why?

Well, nearly 40% of IQPC report’s respondents expect to need up to 24 months or longer to fully implement serialization which means they are unlikely to be ready for the 2017 serialization deadline in the United States and, even if they are, they won’t have much time for testing pilot lines before rolling out their serialization solution across the company or for trial and error during implementation.  In response to whether the European FMD’s 2019 deadline is enough for the proper testing of serialization, 60% of the report’s respondents said yes but only just enough and 12% disagreed completely that it was enough time.

What does this mean for the industry?

Dangers and consequences of being late

The more companies that try to get up to speed in compliance matters at the same time the more likely they will face bottle neck situations, simply because there might not be enough vendors on the market that have enough experience to quickly implement a tailor-made serialization solution for everyone at the same time.

Moreover, the more you rush, the more likely you are to not plan thoroughly enough, not communicate clearly enough with all parties involved (inside your company and among stakeholders) and that you might overlook future needs only focusing on the nearest deadlines.  And it is not only about implementing: you’ll also need time for testing and training your staff. So, if you haven’t started thinking about a serialization solution, do it now.

How to mitigate some of the risks of late serialization implementation

Rushing things is not ideal, especially when it comes to legal and regulatory compliance. However, there are some things you can do to mitigate the dangers linked to tight deadlines.

Choose a standard solution. Standard serialization solutions are designed to be interoperable and to adapt to most existing line equipment. This will avoid you having to renew your whole machine park and minimize software/hardware incompatibilities. If you choose a standard solution with strong level 3 capabilities, you will find it easier to integrate your global network and higher level enterprise solutions. More on why strong level 3 capabilities are a key to success in this whitepaper.

Go for a centrally configurable solution. It will ensure that you can easily integrate regulation changes and be ready to implement future ones. Since no extra development or add-on features are to be implemented at line level, no machine downtime is to be expected. Therefore, it will speed up and facilitate your upgrade and change control processes. Not to mention that the centralization of set-up parameters minimizes the risk for human error. A fully configurable serialization solution will also allow you to centrally organize the attribution of serialization codes, no matter the packaging form of your drugs (bottles, cartons, etc.) and the required coding format for the target market.

While there is no miracle solution to comply within the strict deadlines, the above mentioned points will enable your serialization project to be accomplished as smoothly as possible.

If you want to learn more on how to mitigate risks linked to serialization mandates around the world and, specifically, in the United States, watch this webinar by serialization expert Dave Harty.

JEAN-LUC LASNE
JEAN-LUC LASNE

Jean-Luc is the Business Development and Alliance Director of Adents in Europe. With more than 20 years of experience working with pharmaceutical companies, contract manufacturers or clinical research sites, he has acquired a deep knowledge of packaging and control technology as well as a a clear understanding of the impact of serialization on the production of pharmaceuticals.

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