A Cold Chain Process Validation Guide: Part 6: Performance Qualification (PQ)

A Cold Chain Process Validation Guide: Part 6: Performance Qualification (PQ)

A Cold Chain Process Validation Guide: Part 6: Performance Qualification (PQ)

This six-part article series explores Cold Chain Process Validation, addressing the multifaceted challenges and evolving demands professionals like yourself face in ensuring product integrity from manufacturing to delivery. Amidst economic, technological, and regulatory pressures, the series begins with an overview of the cold chain validation process, emphasizing the need for comprehensive strategies to navigate competing priorities, sustainability initiatives, and the globalization of supply chains.

Click the links below to navigate to each article in the series:

  1. Introduction
  2. Integrating your Cold Chain Management Systems
  3. Developing Mature Quality Systems
  4. Component Qualification / Installment Qualification (CQ/IQ)
  5. Operational Qualification (OQ) for Drug Products
  6. Performance Qualification (PQ)

Three processes must be in place to allow transport validation to be effective – the CQ/IQ and OQ portions of the transport validation process coupled with performance qualification (PQ). As with any systematic approach, validating the integration of your cold chain 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. 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 process’s ability to perform within acceptable ranges in expected commercial transport lanes but doesn’t need to be performed with shipping actual drug products. All applicable process controls will be tested: monitoring and controls placement, training systems, quality agreements and service levels with carriers, receiving procedures, etc.

Monitoring & Control Systems

The PQ execution requires 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 & controls and lane qualification – provide feedback on the transport environment to ensure the transport environment is operating to ensure distribution within the tolerances deemed to be acceptable to the organization.

cold chain validation guide


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 that 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 ongoing confirmation that your validated process is still in control, data is gathered on the performance of your transport lane to show your current and new transport lanes are in control and working within tolerances deemed to be acceptable.

How Modality Solutions Can Help:

The pharmaceutical cold chain network is complex, but Modality Solutions makes it easy to simplify and streamline your cold chain. Working as a professional in the cold chain network means facing daily challenges. Just because the pharmaceutical cold chain network is complex doesn’t mean that your management system must be. Let our focused pharmaceutical cold chain engineering firm deliver results with our advanced technology and world-class engineers.

Here’s what you can expect:

  • Confidence in your cold chain. Guaranteed.
  • Every engagement is led by a principal.
  • You can reach out anytime, anywhere, for anything,
  • We solve real problems. Your cold chain will be approved.
  • You will become cold chain experts.

Contact Modality Solutions

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