By the end of the year, three quarters of the world’s prescription medicines will fall under track and trace legislation aimed at preserving supply chain integrity. Colin Newbould, director of regulatory affairs and QP services at the Wasdell Group, discusses upcoming deadlines and what companies should be thinking about as the scope and requirements of track and trace legislation continue to change.
Future proof
A shifting landscape
Underpinning all incoming legislation is serialisation, hailing a monumental shift for the industry as all drug products will need to be marked with unique and traceable data that allows tracking and verification throughout the supply chain.
However, although the concept of serialisation broadly unites new legislation, no two sets of regulations are the same. Different markets have differing requirements and the current global regulatory landscape can seem like a labyrinth of cut off dates and transition periods.
With key implementation deadlines looming in two major markets — the EU Falsified Medicines Directive (FMD) and US Drug Supply Chain Security Act (DSCSA) — it’s vital for pharmaceutical companies to understand the specific requirements for the regions in which they operate so they can be proactive when implementing compliance solutions.
Third-party expertise
Companies need to consider how long it will take to not only test solutions to ensure they work efficiently, but also to test lines and implement the necessary changes to packaging components. For example, cartons will need to have unvarnished areas added to cater for new lines of text such as GTIN, batch number, expiry dates, serialised data and 2D data matrices.
Tamper evidence measures also add an additional level of complexity, for example, will these be covert or overt? Packages that include braille will also need to be adapted to cater for these systems.
These complexities are leading many companies to look for third-party contract providers to outsource their serialisation requirements to. Those sourcing new partners should be looking for a contract organisation that has already implemented serialisation systems from level 1–4, in other words that has a tried and tested solution already in place.
Think ahead
As the legal landscape for drug serialization continues to evolve and companies must look beyond short-term compliance requirements and the next major deadline to consider how this will adapt to future legislation, both in the markets they currently cater for, markets they intend to enter in the future and relevant markets that are not yet regulated. This will enable pharmaceutical companies to react faster when faced with new legislation.
Future-proofing solutions can be more easily achieved when outsourcing as a partner contract packaging organisation (CPO) can look beyond the day-to-day and will be more versed in the potential requirements that could come further down the line.
Approaching aggregation
One such example of a potential future requirement is aggregation: the process of associating drug product items (‘child’ items) with their case (the ‘parent’). Having aggregation in place means that it is possible to scan a case’s barcode and automatically ascertain the identity of its contents.
Currently, aggregation does not form part of the EU FMD requirements for the 9 February deadline and it will not be required in the US until 2023, when three-tier parent-child relationships between barcodes, on the unit, the box, and then the pallet, will become compulsory.
Nevertheless, integrating aggregation into your approach ahead of schedule will allow you to realise the full benefits of track and trace and deal with any likely future amends to regulations in other markets. It will also help speed up the supply chain and avoid time-consuming manual unpacking and checking processes.
Whatever your preparation status, it’s important not to see the EU FMD as the endpoint for legislation changes — there will be more. Setting up approaches that go beyond the next major deadline and can accommodate future legislation changes provides much more flexibility and peace of mind.