Article | June 21, 2016

Establishing Best Practice Qualification Metrics For Smart Shipping Containers

Source: BioLife Solutions, Inc.
Establishing Best Practice Qualification Metrics For Smart Shipping Containers

By Kevin O’Donnell, Vice President, Cold Chain Standards, Practices & Compliance, BioLife Solutions, Inc.

Wernher von Braun, the father of modern rocketry famously stated, “one test is worth a thousand expert opinions.” The FDA has put their own regulatory spin on this axiom: “if you didn’t document it; it didn’t happen.” This extends beyond the drug therapies themselves to the packaging and logistics practices that are used to distribute them; what the FDA refers to as the “holding” of a drug.1