Clinical-to-Commercial Test Run Playbook

This guide provides a comprehensive framework for clinical-stage biopharmaceutical companies preparing for their first commercial lots. It outlines the critical path for serialization readiness, detailing the necessary roles and responsibilities, including those of the Marketing Authorization Holder (MAH), Quality Assurance (QA), Serialization Lead, and Packaging Operations. The playbook emphasizes the importance of a full-fidelity test run, ensuring that all serialization design decisions are finalized, partners are onboarded, and validation is complete. It specifies the entry and exit criteria for the test run, which includes executing realistic master data and packaging flows. Additionally, the document describes the shipping validation process, which aims to protect product quality across various distribution scenarios. It also lists success metrics and evidence requirements to ensure compliance with market standards. The playbook serves as a practical resource for managing the complexities of serialization in the biopharmaceutical industry.