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Case and Pallet Packaging Under A Serialization Mandate

Capturing high quality aggregation data during the case-packing and palletization operation is essential to efficient operations under a serialization mandate. And what happens when aggregation data is inaccurate?

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A pharmaceutical serialization mandate forces manufacturers to change the way their saleable unit packaging, cases and pallets are identified by adding a unique serial number to each one. Under just about every mandate around the world, new packaging artwork, new shipper labels, and in some cases, new pallet labels are necessary. Once these elements are serialized, packagers need to capture aggregation data—the serial number-based parent-child packaging hierarchy—during the case and pallet packing steps. The accuracy of aggregation data is a critical to the efficient operation of the supply chain where these mandates exist. Manufacturers who do not maintain the highest quality in their aggregation data will eventually be challenged by their customers over the resulting inefficiencies.

Pharmaceutical serialization mandates are slowly sweeping the world. The Russian Federation law will be in full force as of January 1, 2020; the EU Falsified Medicines Directive (FMD) went into full force on February 9, 2018; the Drug Supply Chain Security Act (DSCSA) serialization mandate went into effect on November 27, 2018 after the one year enforcement discretion expired; and there are existing and pending laws in Turkey, Argentina, the Republic of Korea, India, Pakistan, Saudi Arabia and Egypt. In October 2020 the first set of products will need to be serialized in Brazil and it appears that China is poised to impose a new mandate soon. Activities are occurring in other countries around the world that appear to be leading to mandates in the future.

Some of the earlier regulations to go into effect did not explicitly mandate the capture of aggregation data, including the U.S. and the EU, but nearly all since those have included an explicit requirement for it. Even those earlier regulations cannot be met efficiently without manufacturers capturing aggregation data so even though the requirement is not stated, manufacturers should expect to include it in their solutions—especially when drugs are also marketed in other countries.

What exactly is aggregation data and how is it used?

Aggregation data is simply a collection of data that describes the serial number-based parent-child packaging hierarchy of a shipment of serialized products. Aggregation data is unique to products where two or more packaging levels are serialized. The data is captured at the moment when the lower-level serialized packages—the “children”—are placed into/onto the higher-level serialized container—the “parent.” This is illustrated below in a simple, two-level situation.

Figure 1: A simple serialized case-packing scenarioFigure 1: A simple serialized case-packing scenario


As you can see, once the case is sealed, the serial numbers on the units will be hidden and there will be no way to know the serial numbers on the individual packages inside. To capture the aggregation data, the case packing step must include the scanning of the barcodes on each individual package as they enter the case, then scanning the barcode on the case. The relevant information must be extracted from each of these barcodes. Typically, it will include a GS1 Global Trade Item Number (GTIN) and the serial number, but if the case uses a GS1 Serial Shipping Container Code (SSCC), as in this example, then that number would be the data to extract. The aggregation capturing application will need to associate the data from the barcodes on the individual packages with the data from the case label barcode.

Here is the aggregation data for the example above:

Table 1: In this example, the Parent Serial Number Code is an SSCC and the Child Serial Number codes are GTINs plus serial number. Note that the GS1 Application Identifier (AI) and check digits are offset by spaces.Table 1: In this example, the Parent Serial Number Code is an SSCC and the Child Serial Number codes are GTINs plus serial number. Note that the GS1 Application Identifier (AI) and check digits are offset by spaces.

An SSCC is a self-contained serial number for the shipping container. But when a GTIN is present, the serial number is only relative to that GTIN, so for full global uniqueness, the GTIN must be referenced along with the associated serial number. That’s why Table 1 shows both the GTIN and the serial number data elements under the “Child SN code.” The GS1 Application Identifiers (AI) and check digits from the barcode scans are also included in both columns to highlight the individual data elements in the string of characters. When the aggregation data is stored or sent to another party, the AIs are normally removed while the check digits are included, but these details depend on the technical requirements of the receiving party.

In other situations, the Parent SN Code might be a GS1 GTIN rather than an SSCC, and/or the Child SN Code might be an SSCC instead of a GS1 GTIN (for example, when the aggregation data is documenting cases [the Children] placed onto a pallet [the parent]) so capturing applications need to be able to accommodate all possible combinations. Also be aware that the barcodes scanned on either the individual packages or the containers will likely include other data elements that can be ignored when this data is captured and stored.

When this data is shared with a trading partner in the U.S. it is usually stored within a GS1 Electronic Product Code Information Services (EPCIS) Aggregation Event, which is an eXtensible Markup Language (XML) formatted data structure. The format of the aggregation data shared in other countries are often not standardized so check the regulatory requirements or guidance for the target country to find the correct format and transmission method.

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