Daniel Tedham, MD at Wasdell Group, on what it takes to comply with the new European Falsified Medicine Directive
Daniel Tedham, managing director at The Wasdell Group
With the FMD deadline now upon us, it is important that fully compliant pharmaceutical companies think ahead and consider future legislative developments. It is likely as we move forward that there will be changes to the regulations to further improve supply chain security and products' passage throughout the supply chain. By starting to consider potential changes sooner rather later, companies will ultimately be able to respond more quickly to any new legislation and minimise the impact on their operations. If companies start to become complacent, they will fail to effectively adapt to the evolving legal landscape and its requirements across current and potential markets.
The next major step for manufacturers to start exploring is full aggregation capabilities. While it increases the complexity of your supply chain there are numerous benefits to aggregation and implementation will allow companies to fully realise the benefits of serialisation and full track and trace abilities. Ultimately aggregation allows for faster passage of products through the supply chain.
At the Wasdell Group we have already successfully implemented aggregation as part of our investment into our serialisation capabilities, meaning we are already capable of providing three-tier aggregation from carton to pallet. This decision was made because of the significant benefits of aggregation can offer the pharmaceutical industry including, easier verification of a pallet's contents and a reduced requirement for manual unpacking and checking processes.
By enhancing supply chain traceability, aggregation can also allow for improved inventory management control and a sophisticated product recall system. For companies who are still behind in their preparations for the initial EU FMD deadline meeting the next round of legislative requirements will be even more difficult. These organisations should be reaching out to third party suppliers as soon as possible to ensure they are as prepared a possible.
Aggregation also opens the potential of non-EU markets where aggregation is a regulatory requirement and future proofs for any additional legislation that may come along.