Posted on: 20/02/25
When storing valuable products and samples, industries like pharmaceuticals, laboratories and research facilities must ensure their equipment is qualified. We’ve previously discussed the difference between qualification and calibration, but now it’s time to take it further. Equipment qualification is a structured documentation process with four key stages, each designed to confirm proper function, meet industry standards and protect stored materials. In this article, we’ll explore these stages and their role in ensuring success so let's dive in.
Stages of Equipment Qualification
Equipment qualification has four stages, each designed to make sure the equipment works correctly and reliably.
Design Qualification (DQ)
The first stage of equipment qualification ensures the equipment design meets the required standards. This involves documenting evidence to confirm the equipment works correctly before installation. This will also need to prove that the design of the equipment is compliant with GMP (Good Manufacturing Practice) regulations.
Installation Qualification (IQ)
In the second stage, the qualification team makes sure the equipment is set up properly and meets the manufacturer’s requirements. This involves checking that:
- The correct equipment model is installed.
- Required utilities, such as electrical connections and ventilation, are in place.
- The physical setup aligns with safety and operational guidelines.
Operational Qualification (OQ)
In this stage, the equipment is tested to ensure it works as expected under specific, pre-set conditions. Usually in a way that simulates a 'worst case' scenario. This includes:
- Verifying control systems, such as temperature and humidity sensors, are working properly.
- Running tests to ensure alarms and monitoring systems respond as they should.
- Confirming the equipment meets predefined operational parameters.
Performance Qualification (PQ)
During the final stage — performance qualification — the equipment is tested under real or simulated normal operating conditions. This stage ensures the equipment can consistently meet the user’s requirements. Activities in this step may include:
- Simulating storage conditions to test long-term reliability.
- Documenting performance data to confirm stability across a range of parameters.
- Conducting repeatability tests to ensure consistent outcomes.
Why is equipment qualification so important?
All stages of equipment qualification play an important part in ensuring your equipment operates properly. Correctly performing equipment is key in safeguarding your products and samples from temperature changes or other problems that can cause damage or loss. It’s also a requirement set by organisations like the FDA, MHRA and WHO. They stipulate that GMP (Good Manufacturing Practice) equipment in industries focused on quality, safety and consistency is properly checked and qualified.
So, there you have it—the four stages of the equipment qualification process. While they might sound similar, each serves its purpose in ensuring your equipment is reliable, efficient and compliant with industry regulations.
At Contronics, we provide added IQ and OQ on request as part of our qualification service to ensure your equipment is set up and running as it should. Want to learn more about the equipment qualification we provide for our ProLog monitoring system? Get in touch with us today.
