The regulatory frame
WHO Good Distribution Practice
The global reference for pharmaceutical distribution: temperature-controlled storage and transport, qualified shipping systems, deviation handling, and a documented system for who decides what happens to product that saw an excursion. GDP expects the supply chain to hold and prove temperature conditions end to end — including at the handoffs, where most cold-chain failures actually occur.
FDA 21 CFR 205.50 (US wholesale distribution)
The US storage-and-handling rule for wholesale drug distributors: drugs held under conditions described in the labelling, with temperature and humidity controlled and monitored as required — and procedures for handling recalled or returned product. It is the rule a US inspector cites when the chart says the warehouse ran warm.
21 CFR 600.14 (US biologics)
Biological products — vaccines, plasma, gene and cell therapies — carry an explicit expectation of written temperature-control procedures, including for shipment, plus documented review of what happened in transit. This is where 'we shipped it cold' has to become a record.
USP chapters
USP <659> sets packaging and storage definitions — 'refrigerated' means 2–8 °C, 'freezer' −25 to −10 °C unless the labelling says otherwise — and frames qualification of shipping containers. USP <1079> and <1079.1> cover storage and transport risk, including the risk-based excursion assessment: exposure considered against the product's stability data, with mean kinetic temperature (MKT) as the single equivalent-temperature figure for a period of drift.
What is GDP in this context?
Excursion assessment, not excursion panic
A single warm reading does not condemn a lot, and discarding on reflex is its own failure. The accepted method is a risk-based assessment against the product's stability data: how far out of band, for how long, cumulative exposure over the shipping lane, and whether the product has documented tolerance for that exposure. That assessment — with a named decision-maker and a recorded disposition — is the deliverable inspectors want, and it is exactly what a trend of readings cannot produce on its own.
The handoffs are where cold chains break
Most temperature-controlled failures happen at transfer points: the dock, the courier handover, the weekend delivery nobody unpacked. Qualified packaging protects the product between handoffs; process and records protect it during them. Chain-of-custody — which shipper carried which lot, with what coolant charge, checked at receipt — is the thread that ties the transport record to the lot record. Dry-ice and liquid-nitrogen shipments add their own book: the coolant quantity at packing and at receipt is part of the evidence, because for those shipments the temperature data can look flat right up until the coolant is gone.
What belongs in the evidence pack
- Temperature records for storage and transport, with the monitoring interval and the instrument identified.
- Calibration certificates for the probes and loggers behind those records.
- Qualification of shipping systems and packaging for the lane they run.
- Deviation reports: every excursion, with assessment against stability data and a documented disposition by an accountable person.
- Data-integrity posture for the records themselves — the ALCOA+ expectations (attributable, legible, contemporaneous, original, accurate; complete, consistent, enduring, available) are how GxP records are judged, including audit trails and access control.
How Cryovo fits
Cryovo registers each asset's band, detects every out-of-band period, and keeps the band, start, duration, worst value and recovery on the record — the raw material of the excursion assessment. The qualified-person judgement stays where it belongs: with your people.
General information, not legal or compliance advice for your jurisdiction. Applicable requirements depend on product class, market and licence. New to the vocabulary? See the Help page and the glossary.