As a Serialisation Project Manager on a packaging site in one of the world's largest Pharmaceutical companies, he is tasked with implementing solutions to achieve compliance with global regulations, including the European Falsified Medicines Directive.
What is the European Falsified Medicines Directive?
Effective in Europe from February 2019, EU directive 2011/62/EU, also referred to as EU-FMD, aims to reduce counterfeiting of prescription drugs by tracking and tracing the passage of drugs through the entire supply chain.
Under the Directive, all new packs of prescription medicines placed on the market in Europe from the deadline of 09 February 2019 onwards will have to bear two safety features: a verifiable unique identifier (serialised code) and an anti-tamper device.
Insights from a Serialisation Project Manager
For those tasked with achieving compliance with regulations on Track and Trace, here are key points to consider, directly from an experienced Project Manager.
- Educate yourself
Since the first regulations emerged four to five years ago, multiple sources of knowledge and expertise have emerged. Audit these carefully and leverage what the market has learned to date to inform yourself of exactly what is required for your site and the best way to achieve it.
- Vendor selection
There are a number of key players in this space. Evaluate them carefully. Consider aspects such as: experience; expertise; support – focus here on the location, remote support is often not enough.
From your research on market requirements and vendors, build a business case that covers how the regulation affects your site, your product SKUs, your budgets and your people.
Identify, early on, who are the key stakeholders in your project. Engage them early and be ready to educate and explain: what is involved; what is required of them and; the impact you imagine it will have on the business.
- Planning and people
Following approval, draw up a detailed project plan and ensure all functional groups are included at each stage. People will be key to the success of your project and its delivery on time and within budget. Engage people early, let them know what is needed from them and communicate with them regularly to keep the project on track.
As each stage of the technology design progresses, stay in close contact with your vendors (software and automation may come from more than one vendor). Bear in mind any learnings from previous projects that you deem to be relevant. Test systems from your vendor as early as possible for potential weaknesses, even if these are demos rigs.
Another key element in the success of this project will be in the embedding of the systems in your facility. Operators and technicians must understand why the systems are required and be given sufficient training to run the systems confidently.
- Get started
The FMD deadline is fast approaching and this project will take longer than you expect. Vendors have limited bandwidth so mitigate any constraints that you can now and make a move on initiating your project.
The deadline for compliance with the Falsified Medicines Directive is fast approaching. Luckily, implementation of these systems is no longer a dark art. For more information or any queries, don't hesitiate to get in touch with the Serialisation team in Crest Solutions - contact us.
What is Serialisation?
Serialisation is the process by which the pharmaceutical manufacturer, using country specific regulations and GS1 standards, must assign and apply a unique serial number (in both a 2D data matrix barcode and human readable form) to an individual item to be sold to a consumer, this product identifier is recorded on the outer packing.