Beyond The Box: Why Shipping System Qualification Matters In Advanced Therapies

For advanced therapies like cell and gene products, quality assurance extends far beyond the manufacturing suite and into the entire supply chain. One of the most critical steps in safeguarding material integrity is shipping system qualification. This process confirms that the equipment, materials, and procedures used for transport can consistently maintain defined temperature stability and physical protection under real-world conditions. Qualification transforms assumptions into objective, data-driven evidence, establishing proof of performance vital for regulatory compliance.

Reliable logistics also demands preparing for the unexpected. Proactively qualifying backup shipping systems is essential for ensuring business continuity when facing shipment delays, damage, or sudden increases in demand. This documented approach allows operations to respond swiftly to disruptions while maintaining the same high standards as primary systems. Implementing a robust qualification program, covering both primary and contingency systems, ensures inspection readiness, minimizes risk, and builds trust across your entire supply chain.