In this article, Marco Baietti, commercial director at SEA Vision, weighs up the advantages of implementing aggregation, what the future holds and the current levels of adoption within the industry.
Weighing it up
For or against it, aggregation is something to consider as part of a serialisation set-up. In regulatory markets where it is not mandated, there are mixed opinions from businesses as to whether the benefits of aggregation outweigh the investment.
Regulatory outlook
Aggregation is currently mandatory in some countries and in others it is not a legal requirement but strongly recommended by regulators. Some countries in the early stages of developing their regulations will also require aggregation. Additionally, the US Drug Supply Chain Security Act (DSCSA) will require companies to aggregate in the next five years.
Europe’s falsified medicines directive (FMD) is the only large regulation not requiring mandatory aggregation, causing many companies supplying markets covered by the law to question their investment. In Europe, it is estimated that around 30–35% of the market is aggregating, with mainly small and mid-sized companies choosing not to at this stage. But, is this the right decision?
Assessing the benefits
Obvious advantages of aggregation can be seen in the supply chain. Aggregation allows product receivers to scan one code and understand what is in the whole shipment, simplifying the movement and handling of products.
Statistics show that around 2–3% of batches on the market need to be reworked or recalled. Aggregation can help to simplify this process. A good example of this is a pharmaceutical company that decided to implement serialisation only and needs to rework more than 15 million cartons per year during distribution. They are exploring automatic solutions to do this; however, this is likely to cost more than implementing aggregation.
In cases where two wholesalers exchange products, it is necessary to check that the codes and products are genuine and that they have been updated properly in the database. Without aggregation, the receiving wholesaler needs to open all the cases and reprocess each carton!
While aggregation is not mandatory in EU FMD, it is written into the regulations that if any product is stolen during transportation, it should be decommissioned within the database. Without aggregation, it is difficult to know which cartons have been stolen without scanning products manually.
Potential drawbacks
Despite the many benefits, the industry has been slow to adopt aggregation. The financial investment needed to achieve aggregation can be prohibitive.
Overall equipment effectiveness can be impacted by adding additional equipment to the packaging line. However, this can be off-set if the aggregation set-up has involved the purchase of new, more efficient machinery.
There will also be some downtime while the line is being equipped, which can be minimised by using an experienced partner. It is also recommended that aggregation equipment is introduced at the same time as serialisation systems to reduce both downtime and the overall cost of implementation.
During exception handling in the post packaging stage, it is sometimes necessary to split pallets to meet market demand and/or customer requirements or to take some samples from a case. When the cases and pallets are aggregated, it is necessary to de-aggregate and then re-aggregate the cartons to account for any changes.
Summary
Manufacturers must take a global view of track and trace requirements to future proof their business and ensure they can meet demand from new markets.
Many in the industry believe that all the world’s pharmaceutical products will be serialised and aggregated in the next five to 10 years. In an ideal scenario, there will be a single, global track and trace regulation to simplify the market.
Using both serialisation and aggregation, pharma companies will be best equipped to control the whole supply chain distribution system. What is seen as a cost today, will repay pharmaceutical manufacturers with many benefits in the mid-term.