A serialized guide to serialization #2
Serialization, precision, and aggregation
Aggravated? A calm intro to aggregation
Off the bat, we should mention that your serialization requirements will vary based on the countries in which you sell your products - not the country in which you are based. The FDA in the US, for example, requires you to implement serialization, track and/or trace, and verification – whilst China’s CFDA only stipulate infrastructure for serialization and reporting.
All sound a little new? Maybe you missed part one?
Within the requirement for serialization, which is something you will have to do regardless of the area in which you operate, there are various specific sub-requirements to meet. These can be broadly described in three categories:
- The packaging level at which you must serialize your products;
- The manner in which your serial numbers are generated and displayed, as well as which types of product require serialization in the first instance;
- Aggregation of containers and products, and the relationship between small and large groups of products.
Once you’ve determined your requirements, you should begin ensuring that your operation is compliant.
In this part of the guide, we will focus specifically on aggregation.
Precision in serialization
With serialization functioning as a system whereby products are given unique identities which enable them to be tracked, it makes a great deal of sense to ensure that your products can be located to a precise degree. As discussed in the first part of our guide, this is essential for determining if products have gone missing, been tampered with, or counterfeited – but it is also vital for ensuring your products can be shipped to parts of the world with more stringent requirements.
However, if products can only be traced on a binary scale, then it becomes difficult to account for much larger pallets, multipacks, or cases – and this is where aggregation data becomes crucial for a successful serialization strategy.
You might be interested in our article on the US and upcoming serialization deadlines.
By using precise serialization and aggregation technologies, products can be identified, tracked, and safeguarded at every level from the individual dose, to shipping and logistics.
What is serialization aggregation?
Without aggregation, a serialization strategy would simply consist of giving every packet or vial or dose of medicine a serial number of identifying code. Whilst this may sound useful for accounting for very small quantities of stock, as well as ensuring some degree of protection against unidentified adulteration or theft, individual barcodes can be too precise to rapidly identify products. With aggregation, however, larger amounts of stock – a packing box, for example – can be identified as a group.
This parent grouping will then contain child products – usually, individual units.
Without aggregation, you would have to sift through individual items to learn where they are from; with aggregation in place, you can infer the relationship between parent and child far more rapidly.
To make discussions of the different types of serialization clearer, experts usually refer to the five levels of serialization. These range from the unit-level to encompassing the entire supply network. The example of aggregation discussed above would fall into levels one and two in the below infographic.
Aggregation data in the EU and US
Neither the FMD nor DSCSA explicitly state a requirement for using aggregation data, or the sort of data that highlights parent-child relationships in products. However, most companies will wish to have their serialization strategy running as smoothly as possible – this is why the implementation of aggregation data has been a goal for many firms in the past few years.
In the EU, it is likely that aggregation data will soon start to be used to verify the contents of entire shipments – as well as smaller hauls and containers.
This is important to consider when thinking about your security – as any erroneously-transcribed aggregation data could result in you having to dispose of hundreds or thousands of units if serial numbers are not adequately accounted for. Some are also concerned that such high-level data capture could result in many pharmaceutical products not getting scanned further down the supply chain, and risking undetectable unit-level tampering before reaching the point of sale.
See also: Serialized guide to serialization #1.
In the US, a recent report published by the Healthcare Distribution Alliance found that 86 per cent of the enterprises questioned were confident that they would have serialization fully in place by November 2018, but only 38 per cent felt confident that they would be implementing aggregation data by the same deadline.
Another major challenge with introducing data aggregation is the requirement for automated assistance – something many firms seem reluctant to embrace, despite its longstanding availability. Using handheld equipment to code and capture aggregation data is impossible for many medium- and large-sized firms – and the push to update processes will soon become a necessity. If businesses are not prepared to pay for proper automation or to consistently achieve accurate data, misidentification errors could cost far more than the initial implementation of aggregation data.