Pharmaceutical Inspection: Compliance by Design
End-to-end machine vision and serialization solutions engineered for pharmaceutical manufacturing—ensuring DSCSA, EU FMD, and global regulatory compliance while achieving zero-defect production.
Complete track & trace from packaging to patient
Meeting Global Pharmaceutical Regulations
Our systems are purpose-built to address the complex compliance landscape of modern pharma manufacturing
🇺 DSCSA (USA)
Drug Supply Chain Security Act requirements for product identification, verification, and transaction history.
- Unique serial number on each saleable unit
- 2D DataMatrix with GTIN, serial, lot, expiry
- Verification at package level (VRS)
- Electronic interoperability (EPCIS)
🇪 EU FMD (Europe)
EU Falsified Medicines Directive mandates for safety features and repository connectivity.
- Unique identifier (UI) on packaging
- Anti-tampering device verification
- EMVS/NMVS repository integration
- Decommissioning at point of dispensing
🌍 Global Standards
Harmonized approaches for emerging markets and export compliance.
- GS1 standards for data structure
- WHO GDP guidelines adherence
- Local regulatory adaptations (Brazil, China, India)
- Multi-language label verification
Achieving 100% DSCSA Compliance on High-Speed Blister Lines
Challenge: The manufacturer needed to serialize and verify millions of blister packs monthly across multiple sites while meeting DSCSA deadlines, maintaining line speeds of 400 packs/minute, and keeping false reject rates below 0.5%.
- Deployed Unicus Vision Label Inspection + Serialization systems on 8 high-speed lines
- Integrated with existing SAP ME and repository systems via EPCIS 2.0
- Implemented AI-powered defect classification to reduce false rejects
- Established centralized monitoring dashboard for all sites
Pharmaceutical Solutions Portfolio
Modular, scalable systems designed for pharma-specific challenges
Serialization Systems
Generate, print, verify, and manage unique identifiers compliant with DSCSA, EU FMD, and GS1 standards.
Learn more →Track & Trace Platform
End-to-end aggregation from unit to pallet with EPCIS repository connectivity and real-time visibility.
Learn more →Label Inspection
Verify label content, position, and print quality on blister packs, bottles, and cartons at line speed.
Learn more →Pharma Code Readers
High-grade 2D code verification with ISO 15415/15416 compliance and anti-counterfeit feature detection.
Learn more →Ensure Compliance. Protect Patients. Prevent Recalls.
Our pharma specialists will conduct a free gap analysis of your current serialization and inspection processes against DSCSA/EU FMD requirements.