Twenty years
in the cold chain.

A first-in-human program was shipping to three investigator sites on a carrier’s generic summer pack-out. The sponsor could produce transit temperatures but not a defensible qualification for the payload, the duration or the handoffs, and a sponsor audit was six weeks out.

Two seasonal lane qualifications to ISTA 7D, a payload-specific pack-out specification, receipt and release criteria for each site, and a documentation set that tied every claim to a test, a lane and a revision.

Lanes cleared qualification inside ten weeks and the audit closed with no cold-chain findings. The transport section went into the filing referencing the study records rather than carrier promises.

A cell therapy sponsor added two depots to a vein-to-vein chain that had never been audited at that handoff. Dry shipper requalification intervals were undocumented, receipt steps were verbal, and a single excursion had already been closed on assumption rather than evidence.

Dry shipper qualification and requalification schedule, a written receipt and re-freeze procedure, an excursion decision tree with hold and release criteria, and a GDP audit of both depots with a corrective action plan.

Both depots were approved and the custody trail now stands on signed records. Shipments since have moved without a temperature excursion and the decision tree has been used twice to release product with evidence rather than goodwill.