Aggregation and its Importance to Pharmaceutical Companies

What is Aggregation?

In short, aggregation is the undertaking of creating a hierarchic relationship between distinctive identifiers assigned to packaging containers. Companies have been complying with Serialization guidelines for a while now, i.e., the process of labelling each individual unit of medicine with a unique identifier so it can be tracked through the supply chain. However, individual units are not sent through the supply chain piecemeal – they are transported and distributed as part of larger batches, bundles, cases or pallets. Aggregation refers to labelling each of these larger units with their own unique identifier to ease the process of tracking the individual units within the box. Thus, it is meant to ease the process of serialization and greatly enhance transparency in the supply chain. For example, you don’t need to open a case to get the identifiers of all individual unit-level codes inside, or when you unpack a pallet you can easily tell if there are units missing.

Why is Aggregation Important?

Even though aggregation is not required under EU FMD at the moment, it is certainly on the horizon for most markets, if not already implemented. For example, the DSCSA (Drug Supply Chain Security Act) in the USA intends to implement full-scale aggregation by 2023. Russia has already implemented aggregation on some levels. Thus, when it comes to regulations around aggregation, it is not a question of if, it is a question of when. Implementing aggregation-forward practices makes sense for companies from a commercial point of view, because it not only does it help with serialization, it also makes the distribution chain and stock management processes more efficient. It adds visibility in the supply chain by providing clarity without having to unpack pallets and bundles as they move between manufacturers, wholesalers, retailers and other third-party logistics vendors.

What are the benefits of implementing aggregation?

1. Long-term reduction of costs:
   By simply scanning a single code on the largest packaging container, (batch, pallet, etc.) one can get all the required track and trace information of all its contents at once. This not only helps with stock management, but also in case of handling any recalls and reimbursements. The implementation of aggregation leads to a maximizing of product traceability, helping companies reduce the number of products that require recall and reimbursement and recalling only the specific batch or pallet that is suspect.
   
   
2. Control:
   Aggregation is the best way to keep track of every individual packaging unit throughout both the production and the distribution of pharmaceutical products. Having aggregation implemented in a system ensures tracing of products including through parallel trade systems.
   
   
3. Foresight
   The implementing of aggregation in the initial stages means that a company will be prepared to deal with international regulations around traceability in good time, or even before regulations are passed.

Costs:

Logic follows that there will costs involved in the implementation of aggregation across a pharmaceutical company’s supply chain. However, having serialization processes already incorporated will mostly help mitigate these costs.

Conclusion

While most current regulations about the traceability of pharmaceuticals are set in place around serialization and not aggregation, it is a critical component of track and trace, both internally and externally. It is the next logical step, and it is also essentially a business opportunity, given how much it elevates the operating efficiency of your business. Serialization and aggregation are now closely intertwined, and having the proper processes and equipment to manage these complicated procedures is a large step toward total pharmaceutical traceability.

Cosmotrace’s team of experienced professionals have spent years working with every part of the pharmaceutical supply chain. Contact us today to find out how we can help you implement aggregation into your supply chain:

info@cosmotrace.com

Tel: +44 203 097 1597