Implement Pharma Serialisation
Skill Verified ActiveImplement pharmaceutical serialisation and track-and-trace systems compliant with EU FMD, US DSCSA, and other global regulations. Covers unique identifier generation, aggregation hierarchy, EPCIS data exchange, and verification endpoint integration. Use when implementing serialisation for a new product launch, integrating with the EMVS/NMVS, designing DSCSA-compliant transaction exchange, building an EPCIS event repository, or extending serialisation to additional markets (China, Brazil, Russia).
To enable developers and compliance officers to implement robust pharmaceutical serialisation and track-and-trace systems compliant with major global regulations.
Features
- Implement EU FMD and US DSCSA compliant systems
- Generate unique identifiers and manage aggregation hierarchies
- Integrate with EPCIS event repositories and verification endpoints
- Provide procedural guidance for global market extensions
Use Cases
- Implementing serialisation for new product launches
- Integrating with EMVS/NMVS and DSCSA transaction exchanges
- Building EPCIS event repositories for supply chain visibility
- Extending serialisation to additional markets (China, Brazil, Russia)
Non-Goals
- Providing a fully automated, one-click solution
- Replacing core ERP or MES systems directly
- Handling raw data ingress without clear product/market context
Workflow
- Understand the regulatory landscape
- Design the serialisation data model
- Implement serial number generation
- Implement GS1 DataMatrix encoding
- Integrate with national verification systems
- Implement EPCIS event capture
Practices
- Compliance
- Regulatory Adherence
- Data Integrity
- Supply Chain Management
Prerequisites
- Understanding of target market regulations (EU FMD, DSCSA, etc.)
- Product information (GTIN, batch, expiry)
- Knowledge of packaging hierarchy
Documentation
- info:Configuration & parameter referenceWhile the SKILL.md details regulatory requirements and provides SQL/Python snippets, it does not explicitly document all parameters for hypothetical tools or environmental variables.
Code Execution
- info:ValidationThe SKILL.md provides code examples that would typically use validation libraries, but the skill itself does not explicitly demonstrate or require schema validation for its inputs/outputs.
Compliance
- info:GDPRThe skill operates on pharmaceutical product data, which could potentially include personal data if linked to patient dispensing. No specific sanitization for personal data is detailed.
Installation
/plugin install agent-almanac@pjt222-agent-almanacQuality Score
VerifiedTrust Signals
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