We are now six months passed the EU FMD deadline and various organisations like EMVO have begun to ask the authorities to take out sanctions against companies that don’t comply with the FMD regulations. With a recent European report claiming that up to 30% of the 2D codes containing the DSCSA serial number failed to scan, late adopters must understand the business risk they are taking by not complying.
With some form of serialisation expected to cover 80% of the global drug supply by 2022, having a system that can meet stringent requirements outlined in the EU directive will certainly make any subsequent compliance procedure a simpler progression.
Bart Vansteenkiste, global life sciences sector manager for Domino Printing Sciences, highlights five steps that companies need to take to ensure accurate coding and marking.
1. Quality code
Key to the EU’s FMD regulation is the quality of a 2D data matrix code, incorporating all the important information. It must be machine-readable and durable, in some cases, beyond five years. Both laser or thermal inkjet print-based solutions have the capacity to deliver on the eight code quality parameters.
2. A meticulous verification system
Integrating a vision inspection system into a serialisation solution can make readiness happen within two to three months. It’s true that operating your production lines prior to full automation will be labour intensive, but you will have a system or process that allows you to sell your products in EU member states. Additionally, It is a system which it will be possible to add to in the future.
3. Understand what is required
The first thing is to establish how the regulation will impact your business, its processes and assets. Generate a clear and comprehensive statement of what you need to do. This will provide the basis for your vendor selection and form the foundation document for your validation approach. Look beyond your own internal organisation. Consider your extended supply chain and what the requirements are defining for them. Will they be ready on time?
4. Vendor selection and Implementation
It’s important to select a vendor with a mature, proven track record of product implementation experience with a number of early adopters. Producers need to think about the technology stack. Can the selected vendors meet the required expectations from the printers and cameras at level 1? Can they also deliver on those expectations right through to the enterprise level 4/5 EPCIS (Electronic Product Code Information Services) solution needed to manage their data and report to external authorities?
These are complex programmes and you require the best programme and project management capability you can find to execute effectively all the way through to testing and validation in the short time available. It’s too close to the deadline to fail, it’s even too little time for a fast fail, so experienced practitioners are essential.
5. Transition to Sustainability
So, you’re finally FMD compliant – It’s now time to focus on achieving manufacturing effectiveness. It is vital to ensure serialisation becomes a conduit to boost business performance, then you need to make serialisation business as usual – integrating the processes and procedures throughout the wider organisation.