implement-pharma-serialisation
Installation
SKILL.md
Implement Pharmaceutical Serialisation
Set up pharmaceutical serialisation systems for regulatory compliance with global track-and-trace mandates.
When to Use
- Implementing serialisation for a new product launch in the EU or US market
- Integrating with the European Medicines Verification System (EMVS/NMVS)
- Designing DSCSA-compliant transaction information exchange
- Building or integrating an EPCIS event repository for supply chain visibility
- Extending serialisation to additional markets (China NMPA, Brazil ANVISA, etc.)
Inputs
- Required: Product information (GTIN, product code, dosage form, pack sizes)
- Required: Target market regulations (EU FMD, DSCSA, or both)
- Required: Packaging hierarchy (unit, bundle, case, pallet)
- Optional: Existing ERP/MES system details for integration
- Optional: Contract manufacturer serialisation capabilities
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