Serialization has been a key focus of the pharmaceutical manufacturer for the past few years to comply with the global supply chain requirements to fight against counterfeiting of drugs but the benefits of aggregation is still not completely explored by all.
Aggregation helps and makes the distribution chain as well as stock level management more efficient. It helps to find out the quantity and detailed information of stock from a batch that is at different points in the distribution chain by just scanning the barcode on case and/or pallet without the need to open them and repack.
While many companies have been working toward implementing aggregation to support country specific regulatory requirements for Russian CRPT, UAE (tatmeen), US DSCSA to name a few, there are still mixed opinions as to whether investing in aggregation will deliver worthwhile returns in regulatory markets where that is not mandated.
What is Aggregation?
Aggregation is a process of building parent child relationships between different packaging levels of a product. It is not a legal requirement in all the regulations, but it is believed to be very useful especially for the visibility purpose within a supply chain. Aggregation is divided into primary, secondary, and tertiary packaging levels, where the primary level includes the blister pack or folding pack which goes inside the case or shipper (secondary) and the case or shipper is further put inside a pallet (tertiary).
However, each level in aggregation has a unique serial number attached to it and the traceability can be done as per the parent child principle. For example, A blister pack is placed inside a folding box, several serialized folding boxes are placed inside a bundle and several serialized bundles are aggregated to a pallet, however, scanning the barcode of the pallet will provide the information about all the bundles and folding boxes placed inside it.
Why is Aggregation important?
Aggregation helps in checking the final lot count at the close of packaging activities and makes the process more efficient by ensuring the physical packaging lot matches the electronic data. Additionally, it also provides the ability to electronically track all the information during the packaging process and removes the need to open packaged shipper cases and/or pallets to confirm and verify contents in case of any discrepancies.
It also helps significantly in case of product recalls when the product has already been sent for distribution. Aggregation timestamps can be used in addition to the packaging batch record to help understand the point in time where a specific event happened. This allows for the recall of specific units within the packaged lot to be located and securely removed from the supply chain allowing the remaining product to continue in the market.
It is often believed that adding process steps to account for aggregation can reduce the throughput of a packaging line and increase costs, but it isn’t considered that aggregation helps in supply chain optimization and quality management enhancements as there is less time spent identifying, locating, and correcting a deviation during quality checks on a packaging line or after a lot has been released.
Working with an experienced partner can minimize the challenges of implementing and managing aggregation. Providers who specialize in pharmaceutical manufacturing services provide a deeper perspective, giving the customers a granular breakdown of the process and helping them in implementing aggregation for different markets across the globe.
New market regulations against counterfeiting and diversion will continue to come into force around the world in an effort to continue to protect all stakeholders. Whether mandated or not, aggregation can, in the long run, offer pharma companies additional unforeseen benefits such as greater traceability, visibility, and control in the management of their supply chain.
How can CosmoTrace help?
We provide serialization consulting, implementation & integration services to help our clients with managing the end-to-end serialization and aggregation projects and preparing them for the existing and upcoming regulations across the globe.
We are well versed with complications of implementing aggregation process and have successfully implemented it for many customers ultimately helping them in the optimization of their supply chain & quality management process.
Our team of experts strategize and plan end-to-end solutions using a combination of years of knowledge in product serialization, pharmaceutical supply chains, life sciences and brand integrity.
