A Cold Chain Process Validation Guide: Part 5: Operational Qualification (OQ) for Drug Products

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)

Conducting a component qualification (CQ) and installation qualification (IQ) gives us a well-defined specification of system operational capability and tolerances. Operational qualification (OQ) plays a critical role in the transport validation process by testing critical parameters of the system/process at expected extremes while confirming that the process is adequate to deliver unadulterated products.

It is important to conduct OQ tests in a laboratory to ensure that the product is exposed to the expected extremes within the design space of the transport environment. Testing the ‘edges’ of your design space is critical to meeting the expectations of the FDA and their ‘Quality by Design’ initiatives. You cannot guarantee that shipping the product in actual ‘real world’ transport conditions will test your design space. You may not get exposures to desired extreme transport conditions for temperature, pressure, shock, vibration, and humidity at one time, let alone concurrently.

OQ testing should be conducted using PPQ Drug Products or use engineering lots conforming to your PPQ lot as possible. This GMP formulation includes having the drug product in a qualified primary packaging, which is then placed in a representative secondary packaging along with all the labels. The drug product should be placed in an insulated shipper container for drop testing only, which must be packed per a well-defined standard operating procedure. Ensuring proper handling and following standard operating procedures will help in getting an accurate evaluation of the system.

Transport Simulation Testing

The transport simulation test plan will subject all the qualified components to normally expected extremes in the transport environment at the edges of the operating space. It’s important to note that during actual transport, both the product and packaging are subjected to temperature, vibration, shock, pressure and humidity simultaneously. The combination of these environmental transportation hazards can affect a product differently than when exposing the product to these hazards individually. Keeping this in mind, Modality Solutions has designed a multi-modal Advantage Transport Simulation Laboratory that gives you the ability to concurrently simulate these five transportation hazards.

After the completion of the transport simulation OQ test for your drug product, long-term stability studies, and efficacy tests should be conducted on the product to demonstrate that a dynamic transport environment does not affect product integrity.

The last part of this series will talk about the steps involved in conducting a Performance Qualification, which is the last component of the transport validation process.

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.