Europe
The European Commission has published an Aide-Memoire to help both manufacturers and inspectors to verify compliance with the FMD regulation.
Questions listed in the document focus for example on:
- Connection with hub and On-Boarding Partner (OBP)
- Data Flow
- Generation of Serial Numbers (SNs)
- Uploading of information in the repositories system
- Application of the Anti-Tampering Device (ATD)
- Packaging Lines
- Composition, Decommissioning, status change of the Unique Identifier
- Quality of the printing of the 2D barcode
- Alert Management
Source: https://www.gmp-compliance.org/gmp-news/serialisation-new-guidance-for-eu-inspectors