IQ, OQ, PQ

IQ, OQ, PQ

Author Name : Sayali Janardan Bhere, Dr Nitin C. Mohire, Prof. Dhanashree Kathole, Prof. Gauri Bhamare

ABSTRACT These are the abbreviations we use in the medical device industry for the three steps of process validation: Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ). IQ/OQ/PQ ensures that any equipment you use to manufacture your medical device works the way it should—every single time. In the medical device industry, even one failure in a manufacturing process can lead to devastating consequences for patients, so let’s dig into IQ, OQ, and PQ and the role each of them plays in validating your company’s manufacturing processes FDA states that process validation is “the collection and evaluation of data, from the process design stage through commercial production, which establishes scientific evidence that a process is capable of consistently delivering quality product.”To properly complete process validation, manufacturers must carry out and document all three stages of IQ, OQ, and PQ on the equipment they will use to manufacture their devices.