Glossary · Manufacturing systems
Serialization
Also known as: Unit-level serialization, Track and trace
German: Serialisierung
In manufacturing and packaging, serialization is the assignment of a unique serial number to each individual product or package, usually encoded in a data carrier such as a 2D barcode, so each unit can be identified, verified and traced.
- Manufacturing systems
In one sentence
Serialization gives each product or package a unique serial number, often in a 2D code, so each unit can be identified and traced.
Example
Each medicine carton receives a GS1 DataMatrix with product code, serial number, batch and expiry date, uploaded to the verification system.
How it applies
- Engineering: Serialization systems generate or receive serial numbers, print and verify codes on the line and report them to enterprise and regulatory systems. Line, site and enterprise levels share the work.
- Regulation: The EU Falsified Medicines Directive and Delegated Regulation (EU) 2016/161 require a unique identifier on most prescription medicines; the US DSCSA requires product identifiers on prescription drug packages. Medical devices have Unique Device Identification (UDI), which includes serial numbers where applicable.
- Digital product passport: A serialized identifier can link a unit to its passport at item level, depending on the delegated act; see Unique product identifier.
- Documentation: Document the number format, the data flow between systems, rules for rejected or sampled units and the handling of code verification failures.
Serialization vs. lot tracking
Lot tracking identifies groups; serialization identifies individual units.