The EU Falsified Medicines Directive (FMD) deadlines are now live. It is now time to reflect on this massive undertaking, and look at some “lessons learned”. We say this, because we are hearing grumblings in the field that serialization implementation projects are still ongoing. Additionally, the data integration requirements require live data connectivity to repositories like the EU Hub. Finally, when companies create new packaging lines, they will need to be equipped for serialization – wouldn’t it be great to avoid common mistakes from the beginning of the project?
- Believing it’s just a serial number
The EU FMD goes far beyond putting a serial number on a box.
At its heart, the EU FMD is a data integration project on a massive scale. The intent is to house a comprehensive repository of serialized pharmaceutical data to facilitate dispense-moment verification of legitimacy. All of this requires a significant amount of time and effort to integrate manufacturers serialized data with the European Hub – which stores all the information – as well as country-specific hubs with their own dedicated subset of information.
So yes, there are still tamper evidence seals and serial numbers being deployed on individual product units. BUT – there is a secondary, and equally important data integration component to EU FMD compliance. You need to work with vendors who can provide an integration solution and work with you through the comprehensive data onboarding and integration process.
Typically, connectivity to the EU Hub is performed by a Level 4 solution. This is provisioned either from the serialization vendors themselves, or from a stand-alone Level 4 software vendor. Level 4 solutions are typically also track and trace solutions, along with providing the connectivity to the EU Hub. It is critical to pick a Level 4 solution that has proven it has integrated and been certified by EMVO.
Are you hearing that products are scanning as suspect at dispense? Perhaps revisiting your Level 4 solution and integration into the EU Hub is in order. Your integration platform must be scalable enough to handle all the data expeditiously entering the tracking repositories.
- Jumping right in
It pays to remember who won, the tortoise or the hare?
With the aforementioned deadlines coming our way, it may be appealing to just try to get this stuff done, and jump into a project running. Diving into a project like this without doing the proper amount of requirements gathering and analysis will set the project up for failure. Defects discovered in the requirements gathering phases of a project cost anywhere to from 50 to 100 times less to fix than defects that are found closer to rollout.
As projects move along, the cost to change increases dramatically. Having the right stakeholders involved can help discover these design defects much earlier in the project – enabling the cost to fix them to be acceptable. Given the necessary validation of pharmaceutical solutions, fixing defects after validation (which would require a re-validation) is simply unacceptable.
Measure twice, cut once
Equally important to comprehensive requirements gathering is testing. We cannot emphasize enough to not cut corners when it comes to the testing phases of a serialization project roll-out.
FAT (Factory Acceptance Tests) is an inspection that includes both static and dynamic exhaustive testing of systems or major system components to support the qualification a serialization system. The tests must verify that all functionality detailed in the User Requirements Specification (URS) is embodied and performs as specified. It is usually written by the manufacturers and executed by the client or client representative.
SAT (Site Acceptance Tests) is related to the FAT and entails inspection and dynamic testing of systems or major system components to support the qualification of the serialization solution. This is written by the client and verifies that the installed functionality of the equipment meets or exceeds the operational requirements as specified in the equipment URS. The SAT is executed on completion of all commissioning tasks; but prior to the start of “go-live” execution.
Proper project time must be devoted to adequately performing FAT and SAT validations, and ensuring a compliant serialization implementation.
- Not reading the fine print
What is the “real” project time?
Many serialization vendors tout that they can get a customer serialized in a certain number of days – think 45 days, depending on the vendor. Everybody wants to believe that deploying a solution can be as straightforward as a 45-day project. It isn’t. Thinking that you can squeeze all the necessary project elements into that short of a window is a surefire way to not meet the deadline. The upfront requirements gathering necessary to scope a successful project can take 45 days alone. Think of a serialization project as a more realistic 6-9-month journey. Some of the project phases to think about:
- Requirements gathering, including understanding the individual country nuances of the FMD
- RFP’s and Vendor Selection
- Equipment sourcing, delivery and installation
- Serialization hardware and software integration
- Comprehensive testing and training
Systech, for example, has a “Rapid Compliance” program. This is scoped to specifically call out the serialization-specific project components. Our program works with the customer to get the serialization project up through FAT and SAT. It leverages our experience in being deployed on over 1,600 serialized lines, and our knowledge-base of implementations. It is important to note EXACTLY what a vendor is committing to in serialization programs that call out the number of days to get implemented.
- Believing the price is the price
Not all quotes are created equal.
Serialization is being thrust upon pharmaceutical manufacturers whether they like it or not. Nobody is a fan of additional costs in the manufacturing and distribution process, and serialization introduces significant new costs. There are several serialization vendors, all of which will be generating quotes for solutions to make manufacturers compliant with the FMD. It is important to note that all quotes are not created equal.
Is the quote for one line only? Does the quote include all services required to go from requirements, through to FAT and SAT, Validation and Go-Live? Is it a comprehensive multi-line quote? Are there defined project days identified? Is data integration to the EU Hub called out and scoped?
With 2019 FMD deadline now past us, being delivered comprehensive project pricing will have multiple benefits. It will help you create budgetary cost-certainty, enable you to better plan for various stages of this multi-phased project, and establish confidence with your internal team and selected vendor that the project will be delivered on time and on budget. Most importantly, it will ensure that new lines that need to be serialized will be up, running and compliance-ready on time.