Use Case –Label Inspection, Pharmaceutical Challenge: • Comply with FDA Drug Supply Chain Security Act (DSCSA) which requires a DataMatrix barcode for prescription pharmaceutical tracking / “serialization” • Verify barcode quality and content on product and case labels per GS1 & ISO specs • Labels include human & machine-readable information: National Drug Code, serial #, lot #, and expiration date • 1D/2D codes content & print quality inspection per GS1 & ISO specs • Additionally, inspection of label contents required to meet 21 CFR Part 211 є Manual inspection of labels is costly and error prone • Contract manufacturers and those exporting to U.S. also impacted Solution:
• Microscan LVS Verifiers є Off-line (95xx line) with IQ/OQ for validated environments, 21 CFR Part 11 ready є In-Line (75xx) є USP: Off-/In-line consistency Phased implementation • 2017 for manufacturers • 2018 for re-packagers