Understanding Commissioned Serial Numbers

By November 10, 2015 April 30th, 2018 Aggregation, Company News, DSCSA, Global Markets, Serialization

When it comes to event data for serialized products, many individuals are confused about both the events and the data. Take commissioned serial numbers for example: commissioning is the event, serial numbers are the data. But when those three words are used together, they don’t always mean the same thing to different people.
A few weeks ago, I represented my CMO client in a meeting with one of their large pharma customers. The customer requested my CMO client to provide commissioned serial numbers. When I asked the customer to clarify what they meant by commissioned serial numbers, they said the serial numbers associated with the inventory in the shipment. They explained that they only want serial numbers that will be introduced to commerce. The serial numbers of the rejects and the samples are inconsequential in their persepective because those numbers will never be in commerce, so this information is irrelevant to their business.
data eventsThis customer interprets commissioned serial numbers very differently from the way GS1 defines them. I decided to ask several other pharma clients what their understanding of commissioned serial numbers was in order to gauge just how many mixed definitions were floating around out there. It turns out many think commissioned serial numbers are the serial numbers at production release or at shipping. I want to use this opportunity to get the facts straight and explain exactly what commissioned serial numbers are. Let’s first look at the definition of Commissioning from GS1:
“Commissioning is the process of associating an object (e.g., bottle, case, tote, pallet, etc.) with an EPC (i.e., an identifier representing a GTIN / Serial Number, SSCC, etc.). The EPC may be encoded in a data carrier (i.e., a barcode or EPC/ RFID tag) and applied to the object during this step, or the data carrier may have been previously encoded.”
In other words, just before printing a serial number on a bottle, the serial number is commissioned to the bottle. Commissioning means assigning a serial number to the bottle, which happens prior to product release or shipment. During a serialized packaging run, the serial numbers are first provisioned, then commissioned, then decommissioned for rejects, and finally they are shipped. Here is a example of a package order for a serialized product: 10000 serial numbers are provisioned to the batch. Of those, only 9000 are commissioned. Out of the 9000, 10 are pulled out for samples and 100 are rejected due to quality reasons. At the end, only 8,890 units are shipped.

If my customer requested commissioned serial numbers, they would receive 9000 numbers instead of the 8890 numbers they think they are getting. Whether or not receiving only shipped serial numbers is sufficient is another story. I will write about that in my next blog. Stay tuned.