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What is the difference between a serialization and aggregation system?

Serialization and aggregation both rely on the use of unique numerical identifiers, but they are different in scale. Serialization functions on the level of an individual packaged item. Aggregation takes those individual items and bundles them together into a single reference code. Aggregation functions on multiple levels – a group of individual items become a case, cases become a pallet, pallets become a full container, etc.

Download the White Paper to Aggregation

Download the White Paper to Serialization

What products require aggregation?

For pharmaceuticals, in most countries, aggregation is not a requirement. Changes to regulations are ongoing and many countries continue to add aggregation requirements to help minimize the opportunities for counterfeit operations to gain entry into pharmaceutical distribution networks. Additionally, distributors in the US in particular have been instrumental in pushing manufacturers to aggregate products. When the US DSCSA went into enforcement starting in 2017 (and finalized in 2019), aggregation was not a requirement, however major distributors instructed pharmaceutical companies to aggregate in anticipation of legislation in the coming years. This was very forward thinking, as the US is anticipated to start enforcement of aggregation in 2023. This aids in the process for complete documentation of the chain of custody throughout the supply chain and, for distributors, makes it easier to track down a recalled product or document a potential counterfeit.  

How does aggregation benefit my production and distribution process?

Aggregation's real strength comes in the distribution process. Being able to see precisely where each individual item is as it journeys through the supply chain is a crucial element of an effective tracking program, and aggregation makes that process easy. Aggregating codes together means that as long as a container remains properly sealed, a complete manifest can be easily obtained and recorded at any point. 

Why should I aggregate?

Depending on your industry, you might be required to do so to ensure compliance. Beyond that, track and trace aggregation technology delivers security and peace of mind when it comes to the authenticity of your product at the point of sale. Having a complete recorded chain of custody from the moment a product leaves your production facility can illuminate weak spots or leaks in the supply chain. Additionally, this can make executing a product recall much simpler, as governments, third party suppliers, distributors and retailers can more easily identify the affected products.  

Guide to Track & Trace Technology for use in the Pharmaceutical Industries

Guide to Track & Trace Technology

Building an Effective Program

Serialization and aggregation solutions brochure

Software Solutions for Serialization and Aggregation

Protect against counterfeits, comply with industry regulations and improve supply chain management

Artesan Pharma Implement Serialization Early

Early Implementation of Serialization

Artesan Pharma Lead the way for serialization initiatives in Germany