Epista Q&A: Understanding the Scandinavian Serialization Landscape
Preparing for the EU Falsified Medicines Directive (EU FMD) regulations presents significant hurdles for any pharmaceutical company, but can be particularly challenging for the small- to-mid size ones. Epista Life Science provides a broad range of consulting services in the serialization, track and trace
We recently spoke with Epista Principal Serialization Consultant Jesper Ilm to understand what these pharma companies are facing as they look to be ready by the February 9,
What is the pharmaceutical landscape of Scandinavia?
In Scandinavia, the early adopters are a group of primarily top international
What’s the degree of readiness in Scandinavia right now for EU FMD?
Serialization projects are very complex, with everything in play: production, IT, regulatory affairs, marketing. The lines in the Scandinavian countries have many years
When do companies need to start preparing for EU FMD?
Many mid size
It’s important to create a user requirement specification (URS) document as one of the first things you do because you need to get your vendors aligned. Talk to each of your partners, and start a year in advance because if you're a year late, you can't sell your product.
Some of our contract manufacturer customers have actually seen the light and kick-started their projects so they can contract out their lines and take some of the production from contract manufacturers that are not ready. These small contract manufacturers, with maybe 10 production lines, are ready within six months, so they can get business from all the ones that haven't started yet.
What makes serialization quality and validation requirements so complex?
We often hear, “What’s the big deal? It’s just the system we need to implement.” While that’s true, when you change something on the box of a pharmaceutical product, you need to inform all the authorities that you're making changes to these pre approved designs. You need to involve everyone in packaging, regulatory, and marketing. Your IT department has a system that needs to communicate through the internet with a high volume of
It is a big mistake to think it is an IT system that needs to be implemented. That's not true. It is a cross-organizational project, and the quality part needs to be in focus because when you implement a Level 1-5 system, you must have the sequence right. You need deep validation, qualification, and quality guidance from the beginning. You have communication updates going across various systems, and you cannot show the functionality unless everything is ready at exactly the right time.
A Level 3-5 system is a computerized system, but you can't release it in a production environment until you have done end to end testing to verify that the production line is receiving the serial numbers
How is the partnership between Epista and TraceLink helping customers meet EU FMD regulatory requirements?
TraceLink has a methodology that is very thorough and a product that guides the customer in the right direction, especially for mid-size and smaller companies that aren’t used to communicating with regulative authorities' databases. The setup is easy and helps companies in Europe and Scandinavia that don't have IT departments with two or three hundred people. Together with the advisory and implementation services from Epista, pharma companies have a much better chance to meet upcoming deadlines.
It’s important to me that we make a difference, but also that we make a difference on the right quality level. Our partnership with TraceLink is valuable because we are in the same market, delivering a lean approach to serialization implementation projects.
Jesper Ilm is Principal Consultant, Serialization Specialist, and Lead Auditor at Epista Life Science. Jesper brings 25 years of pharmaceutical industry experience, including IT, regulations, computer system validation, infrastructure compliance, ERP, GMP, and pharmacovigilance. He specializes in preparing validation and qualification documentation for serialization and