The GS1 DataMatrix is the standard 2D barcode for pharmaceutical packaging, used in DSCSA, EU FMD, and most national drug traceability systems. DataMatrix encodes data in a square or rectangular matrix of black and white cells and can store significantly more data than traditional 1D barcodes in a smaller footprint.
GS1 Application Identifiers
GS1 Application Identifiers (AIs) define the meaning of data elements encoded in a barcode. Key AIs for pharmaceutical serialisation include: AI (01) — GTIN; AI (17) — Expiry Date; AI (10) — Batch/Lot Number; AI (21) — Serial Number. The combination of these four AIs in a DataMatrix barcode meets the requirements of DSCSA, EU FMD, and most other drug traceability regulations.
Print Quality Requirements
Pharmaceutical DataMatrix barcodes must meet minimum print quality standards to ensure reliable scanning throughout the supply chain. ISO/IEC 15415 defines print quality grades from A (highest) to F (lowest). DSCSA and EU FMD require a minimum print quality grade of C. Key quality parameters include: symbol contrast; modulation; axial non-uniformity; and unused error correction.
Verification
Barcode verification is the process of checking that a printed barcode meets quality standards before the product leaves the packaging line. Inline verification (checking every barcode on the packaging line) is preferred over offline sampling. Verification equipment must be calibrated and certified to ISO/IEC 15415 standards.