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

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

Written by Modality Solutions

Posted on: September 5, 2017

Part four of a four part post on the validation of the transport process focuses on the Performance Qualification (PQ) portion of transport validation. In the previous three posts I covered the processes that must be in place to allow transport validation to be effective – the CQ/IQ and OQ portions of the transport validation process. As with any systematic approach, and validating the integration of your cold change management systems is no exception, each step builds on the previous one. Without strong qualification steps beforehand, any PQ would be at risk – especially without the design space properly characterized. And without proper characterization of your cold chain, it would be difficult to explain any discrepancies if you have issues during the PQ.

The PQ tests the ability of the process to perform within acceptable tolerances and should be performed with shipping actual drug product in ‘real’ transport lanes. Alll applicable processes will be tested: pack out instructions, training systems, quality agreement and service levels with carriers, receiving procedures, etc. The PQ test will ensure all aspects of the transport process can achieve acceptable quality levels. By performing product assays on the product at the completion of the PQ test, you can show your cold chain management processes are in control and have no impact of product quality. Your release assays consistent with lot release acceptance criteria are a ‘gold standard’ to rely upon.

The PQ test is where it is important to have monitoring & control systems in place. This data can be used later during lane qualification of new cold chain lanes implemented after performance qualification is executed. If your new transport lane through your lane qualification process shows similar ranges of environmental hazards tested in OQ and verified in PQ, you can have a high level of confidence your validated transport process will work flawlessly in your newly implemented transport lane. These two processes – monitoring and controls and lane qualification – provide feedback on the transport environment to ensure the transport environment is operating with the tolerances deemed to be acceptable to the organization.

To summarize, the qualification of the components that will be shipped (primary packaging, secondary packaging, insulated shippers) will provide your organization with a high degree of confidence they can be transported safely within a well-characterized design space. Performing OQ testing in a laboratory environment will show that when these components are combined they work together when subjected to simulated transport extremes and deliver unadulterated product to the patient. Finally the PQ verifies that you have robust and well integrated cold chain management processes. With the inclusion of a monitor & controls and lane qualification process for on-going confirmation that your validated process is still control, data is gathered on the performance of your transport lane to show your current and new transport lanes are in control and working with tolerances deemed to be acceptable.

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