Passive & Active Shipping Systems for Temperature Control: Qualification, Data Review & Change Management Validating Passive and Active Shipping Systems for Pharmaceutical Cold Chain Integrity As global distribution of temperature-sensitive pharmaceuticals becomes more complex, ensuring thermal protection through validated shipping systems is paramount. Whether using passive gel-pack-based shippers or powered active containers, each method must be rigorously qualified and maintained under a well-documented validation strategy. This guide outlines the qualification process, data review practices, and change management strategies for passive and active shipping systems — in line with WHO GDP, EU GDP, and FDA expectations. 1. Overview of Passive and…