Implementing pharmaceutical serialisation is a complex, multi-year project involving packaging line upgrades, IT system integration, and supply chain partner coordination. This guide provides a structured implementation approach.
Phase 1: Assessment and Planning
- Conduct gap analysis against target regulatory requirements (DSCSA, EU FMD, etc.)
- Inventory all packaging lines and assess serialisation readiness
- Define serialisation system architecture (L1-L4)
- Select serialisation technology vendors
- Develop project plan and budget
Phase 2: System Implementation
- Install serialisation management system (L4)
- Upgrade packaging lines with printing, vision, and rejection systems (L1-L2)
- Implement aggregation systems for case and pallet serialisation (L3)
- Integrate with ERP and warehouse management systems
- Implement EPCIS reporting capability
Phase 3: Validation and Go-Live
- Conduct Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ)
- Validate serialisation data accuracy and completeness
- Conduct end-to-end testing with trading partners
- Train operators and quality staff
- Go-live with parallel running period