IQ/OQ/PQ Qualification: an overview

Discover the importance of the qualification process in laboratories operating under GMP and GLP environments

In the world of production and quality control, especially in laboratories operating under GMP (Good Manufacturing Practices) and GLP (Good Laboratory Practices) standards, the qualification process is vital to ensure the efficiency, quality, and reliability of equipment and processes. Within this context, there are three critical levels of qualification: IQ, OQ, and PQ.

Installation Qualification (IQ) is the first step in the qualification process. This phase is designed to verify that the supplied unit conforms to the manufacturer's specifications. The idea is to ensure that everything is correctly installed and ready to move to the next stage. As part of the IQ, it's also common to include maintenance, cleaning, and calibration procedures, often referred to as Standard Operating Procedures (SOPs).

After installation, Operational Qualification (OQ) comes into play. This stage is crucial during the development of a process, such as sterilization. Here, tests are carried out to ensure that the equipment, for instance, a media preparator, operates consistently and repeatably within set limits. If any deviation arises, it's the engineers' task to identify and resolve the root cause, ensuring that the equipment always produces the desired result.

Finally, we have Performance Qualification (PQ), the last barrier before entering full-scale production. In this phase, the objective is to confirm and document that the equipment is operating consistently in a real production scenario. PQ tests, conducted over a defined period and under normal conditions, simulate daily production in terms of materials, procedures, and controls. Again, if any deviation occurs, it's imperative to address the underlying cause.

For laboratories and companies aiming to ensure their processes and equipment meet the highest standards, we offer top-tier qualification services. Whether you require a comprehensive IQ/OQ/PQ qualification or specialized documentation to conduct the qualification, our expert team is ready to assist you.

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