Barcode Match: A DSCSA Aggregation / Inference Verifier
At the halfway mark in the decade-long establishment of FDA’s drug tracking system, the track and trace aspect seems to be the most daunting part of the puzzle. Barcodes provide Aggregation and Inference, which is the basis for pharmaceutical supply chain security. How will this work?
Aggregation is a new term for a well-established packaging hierarchy scheme that has worked well for years in the consumer products supply chain. The UPC barcode (aka GS1 GTIN-12) identifies an item as a consumer sale unit. Twelve of those sale units comprises a case, which is marked with an ITF-14 barcode (aka GS1 GTIN-14) and a different GTIN-14 could be used to identify (let us say) a master carton. A pallet of (let us say) 24 master cartons could comprise a pallet, which would be marked with a slightly different GTIN-14. Each of those barcodes, from the GTIN-14 on the pallet to the GTIn-14 on the master carton to the GTIN on the case to the UPC on the consumer item represent what could be viewed as set of relationships. Each level of packaging aggregated into a larger set of packages; each relates to others in the set.
Inference derives from the aggregated relationships of the packaging hierarchy. It is from that relationship that you can infer that all of the items in each level of packaging belongs there. No alien or orphan items are present, and each item is present in its correct number—there are no missing items.
There is concern that this might be too much of an extrapolation for security in the pharmaceutical supply chain, but it has worked for decades in other supply chains, although the consequences of errors may not be as severe as they could be in pharma. However, as in other supply chains, the integrity of the inference depends heavily on the accuracy of the aggregation. This is where code match plays an important role.
A barcode scanner at the packaging line reads each item going into a case, master carton or pallet. System programming accepts only a pre-determined barcode or set of barcodes from being packaged. Personnel monitoring the process can use a handheld scanner. Here are the steps:
- Program a barcode scanner to identify a pallet by scanning its barcode from a menu, work order or from the pallet itself. This is the “parent” barcode.
- Program the contents of that pallet by scanning the master carton barcode from a menu or work order and entering the number of master cartons that must be on the pallet. This is the “child” barcode.
- Save the aggregated set for current and future use.
The contents of a shipment can be multiple copies of the same item, or a mix of many different items—it does not matter to the program. What matters is that the aggregated “child” contents are always the same under the identified “parent” carton.
Fixed mount scanners require that the barcodes always be in the same location as they travel down the conveyor. This can be a problem with cartons of various sizes. Handheld scanners are a flexible solution but can be prone to damage and loss. A recent innovation is an Android app installed on the user’s smart phone.
See the Barcode Match video here.
Download the app here.
Comments are always welcome.