Any equipment used in medical device manufacturing must meet strict industry requirements to ensure safety, performance, and consistency. The FDA regulates machinery used in these important processes using three main standards: IQ, OQ, and PQ. These protocols build off one another and require careful planning and execution by manufacturing facilities. Here’s a guide for those looking for medical device manufacturing support. 

IQ

IQ stands for Installation Qualification, a standard meant to ensure that equipment is installed correctly. It’s the first step in the validation process for equipment that produces or handles FDA-approved products. The process involves inspecting the newly installed equipment and confirming the presence of all necessary documentation and manuals to ensure smooth operation. Teams should also establish maintenance and calibration schedules during this step. 

OQ

OQ stands for Operational Qualification. This step is performed after the equipment is installed and meets all qualifications for IQ. During this phase, operators verify that equipment operates according to industry standards. It involves completing tests on various components to make sure they meet pre-set thresholds, even in challenging conditions. The exact tests run vary based on the type of equipment, but testers may measure output or other factors as the machinery operates. 

PQ

PQ stands for Performance Qualification. The third step validates the stability of manufacturing processes over time. The purpose is to ensure that medical devices offer the same performance and benefits no matter what conditions the manufacturing equipment is exposed to. 

To complete this step, operators run the equipment several times under various operating conditions to track any potential performance variances or changes. Equipment that meets this qualification demonstrates stable performance in various conditions over time. 

If you’re looking for a quality medical device manufacturing partner that meets these important industry protocols, contact Pacific Integrated Manufacturing in Bonita, CA. With more than 20 years in business, the manufacturing company offers an array of options to allow companies to completely customize the experience, from kitting and packaging to injection molding services. Visit the website to see a full list of options, or call (619) 921-3464 for a consultation.