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

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

Written by Modality Solutions

Posted on: September 5, 2017

The US FDA, EMEA, ICH, and host of other regulatory agencies have issued guidance documents on principles of process validation. However, most do not address transport issues specifically. The requirement to validate all critical-to-quality processes remains. What should you do? Read on to better understand how your transport network can be validated!

Cold chain transportation can be validated just like any other process. The goal of process validation is to create a robust process that consistently produces product with minimal variation. Your goal for your distribution processes are the same. By applying good validation principles to your distribution processes, you can validate your transport process. This approach requires qualified packaging and equipment (i.e. over-the-road trucks, active refrigeration units, etc.) and new approach to process definition for your cold chain transportation network.

It starts by integrating your cold chain. By integrating your cold chain, you ensure that all the processes are working together to achieve a common goal – to deliver quality medicines to the patients who need them. A compliant cold chain management system is composed of a variety of components working in concert. An integrated cold chain management system will ensure control of the distribution chain and consequently maintain the quality and the integrity of products. An integrated cold chain has the following elements:

• Quality Systems • Risk Management • Product Stability • Qualification/Validation • Logistics Management • Partner Management • Compliance Management

These processes working together can produce consistency within the transport process which allows transport to be validated. Stay tuned for next week to discover the first step in the qualification/validation approach.

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