This is our third post on item-level serialisation in the pharmaceutical industry. For a primer on the how, what and why, read our recent articles:
>> 4 item-level serialisation challenges for pharmaceutical businesses
>> 5 benefits of item-level serialisation for pharma businesses
Each pack is a batch of one
With item-level serialisation, data will be unique to each pack rather than each batch. Think of every item you produce as having two parts: a physical asset and a data asset. The association between the two must remain linked from the moment identity is assigned to the moment medication reaches the patient. It’s all about proving the authenticity of each product.
The symmetry between the data and the physical asset must be open to interrogation for the lifespan of the product and beyond. This presents significant packaging and data management challenges. If a pack is rejected or otherwise removed, how is it removed from the database? How do you make sure the integrity of serialisation is uncompromised throughout the supply chain?
A data deluge
Think about how many individual packets of medication you process each year. Your system needs to manage a data file for each and every one of them. We are talking about huge amounts of data here, with salient knock-on effects beyond the installation of new equipment - such as the need for increased IT investment, increased staff investment and stakeholder engagement. Casting the move to item-level serialisation as an engineering issue only is grossly underestimating the challenge. Almost every business function in the pharmaceutical industry is impacted.
From packet to pallet...
The move to individual packet labelling does not remove the need to track batches and pallets, which still need to be verified at the point of sale and dispensing. This brings into question another challenge: hierarchical association - how the data for each pack in a bundle, each bundle in a case and each case in a pallet can be retrieved with a single scan. Establishing these hierarchical associations enables any party authorised to handle the product to interrogate precisely which items the batch contains.
A uniform data management system is logical - but it doesn’t exist yet
The deadline for legislative compliance among the majority of EU member states is expected to be sometime in 2017. Now is the time to act. Given the data challenges - and the need for various parties in the supply chain to be able to access data - a uniform, industry-wide data management system seems logical. Yet there is currently no protocol for uploading data to a central repository. To date it’s unclear how data will need to be supplied to regulators and what the obligations are on the manufacturer to replicate and retain information.
The data challenges regarding item-level serialisation cannot be overstated. One of the benefits of reacting early to the impending legislation is that you will be able to help shape the policy governing data management, pushing for a system that favours cohesion over chaos.
You can read more on how to combat the pharmaceutical serialisation challenge in our free white paper.