Pharmaceutical Serialization and Track-and-Trace Audit Checklist

A comprehensive checklist for auditing pharmaceutical serialization and track-and-trace systems to ensure compliance with global regulations, enhance supply chain security, and combat counterfeit drugs.

Pharmaceutical Serialization and Track-and-Trace Audit Checklist
by: audit-now
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About This Checklist

Serialization and track-and-trace systems are crucial in the pharmaceutical industry for ensuring product authenticity, enhancing supply chain security, and combating counterfeit drugs. This Pharmaceutical Serialization and Track-and-Trace Audit Checklist is designed to comprehensively evaluate the implementation and effectiveness of serialization processes throughout the pharmaceutical supply chain. By assessing factors such as unique identifier generation, packaging line integration, data management, and regulatory compliance, this checklist helps pharmaceutical companies maintain robust anti-counterfeiting measures. Implementing this audit process can significantly improve product traceability, enhance patient safety, and ensure compliance with global serialization regulations.

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Industry

Pharmaceuticals

Standard

EU Falsified Medicines Directive, US Drug Supply Chain Security Act (DSCSA), GS1 Standards

Workspaces

Pharmaceutical packaging facilities and distribution centers

Occupations

Serialization Project Manager
Supply Chain Specialist
Packaging Technology Manager
IT Systems Integrator
Regulatory Compliance Officer

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