Transport Validation

Transport Validation

Ship, Quarantine, or Discard: A Streamlined Process and Analytical Tool Yields Better Decisions on Resolving Temperature Excursions

It’s estimated that seven out of ten pharmaceutical products in the US require temperature control during transportation1, a trend that’s escalated with the rapid...

Transport Validation

Why Traditional Data Loggers May No Longer Meet FDA Regulations for Pharmaceutical Shipments

Temperature data loggers have been around for decades and were one of the first sensors in the biopharmaceutical cold chain. This technology provided temperature...

Transport Validation

It Is Never Too Late to Document Your Cold Chain Process Validation Approach

Documentation strategy for your cold chain management validation practices has evolved over the last several years. The FDA and other regulatory agencies are requesting...

Transport Validation

A Process Validation Guide for Cold Chain Logistics

First published on September 16, 2015 on Cold Chain IQ – as a contributor, Hutchinson’s column, Global Cold Chain Connections, falls in the Supply...

Transport Validation

From the Mailbox…When is good enough, good enough?

Note to readers: I wanted to share the following email and reply, since it really gets to the heart of Quality by Design in...