Transport Validation

Transport Validation

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

First published on May 24, 2016 on Cold Chain IQ – as a contributor, Hutchinson’s column, Global Cold Chain Connections, falls in the Supply...

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...

Transport Validation

Transport Process Validation – Performance Qualification (Part 4 of 4)

Part four of a four part post on the validation of the transport process focuses on the Performance Qualification (PQ) portion of transport validation....

Transport Validation

Transport Process Validation – Operational Qualification (Part 3 of 4)

Part three of a four part post focuses on the Operational Qualification (OQ) portion of the transport validation process. As discussed in Part Two,...

Transport Validation

Transport Process Validation – Component/Installation Qualification (Part 2 of 4)

Part two of this four part post will focus on the Component/Installation Qualification (CQ/IQ) portion of transport validation. In the previous post I listed...

Transport Validation

Transport Process Validation – Outlining the Process Steps (Part 1 of 4)

The US FDA, EMEA, ICH, and host of other regulatory agencies have issued guidance documents on principles of process validation. However, most do not...