Guide

GDP Temperature-Controlled Pharmaceutical Transport: A Compliance Guide

Download the GDP cold chain guide: three validated temperature ranges, QP release and controlled-substance clearance, 10-minute logger cadence, deviation procedure and a 22-hour zero-excursion case.

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Who this is for

Logistics managers, QA and QP delegates, and clinical supply leads who have to answer for a temperature record — not just produce one.

What's inside

An excursion is a patient safety event · GDP, GMP and GCP: what each one governs · The three validated temperature ranges · Containers, qualification and monitoring · Four-step shipment process · Documentation set · Deviation handling procedure · Handover and chain of custody · Case: IMP at 2–8°C, Basel → São Paulo, 22 hours · Before you release the shipment · FAQ

What you'll take away

  • Why active cooling beats an insulated box with dry ice — the latter decays unpredictably across ramp waits and customs holds.
  • A deviation procedure that ends in a decision, not in a PDF: who assesses it, who signs the release, and what we supply versus what we are not allowed to decide.
  • The identity chain we maintain for IMP — who packed it, who loaded it, who received it, and at what time each handover happened.

Send us your SOP. We will map our process to it — container type and qualification, route, monitoring cadence, and the exact document set that ships with your product. service@flashgl.com · +86 400-011-9188 Request a quote

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