As with other healthcare-related businesses, the medical device manufacturing industry is a highly regulated one. Before a machine or equipment can be sold, installed, and used, it must undergo and pass the quality assurance standards—IQ, OQ, and PQ—recommended by governing agencies. Here’s everything to know about it.

What Do IQ, OQ, and PQ Mean?

IQ, OQ, and PQ are good practices that medical device manufacturing companies must perform and adhere to before putting their products on the market. As protocols, a manufacturer will carry them out sequentially to check their production process’ consistency in creating quality outputs.

IQ, which stands for Installation Qualification, ensures that the parts and subsystems have been installed and configured based on the requirements and design specifications. Under this step, a checker will confirm that a device has the necessary parts to function as expected.

OQ stands for Operational Qualification, and it checks whether the equipment works as intended. This phase involves identifying and validating a machine’s features that can affect product quality. A checker will test all the items on the checklist to see whether the device’s performance is consistent with the manufacturer-specified ranges or limits.

PQ, or Performance Qualification, is the final step in the validation process. During PQ, the tester verifies stability over time by repeatedly running the equipment under expected operating conditions. It aims to demonstrate the process’ capacity to produce an output that conforms to the requirements.

What’s Their Significance in Medical Device Manufacturing?

The three-step validation process for medical devices is important simply because these types of equipment should be safe enough to be used on people. In conducting IQ, OQ, and PQ, there’s an assurance that healthcare products have met the requirements and regulatory standards on functionality and safety. It reduces the risk of injuries, prevents the high cost of recalls, and ensures the equipment consistently delivers reliable and accurate results each time.

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