Position Paper: Are We Abandoning IQ and OQ?

It has been quite apparent to some of us in the pharmaceutical and medical-device industries that there appears to have been a directed effort over the past number of years to eliminate the concept of and need for the installation qualification (IQ) and the operational qualification (OQ). These two techniques were developed by the industry in answer to the validation requirement mandated by the US Food and Drug Administration (1). The purpose of IQ and OQ was to verify that equipment and systems were able to perform as intended.

Over the years, with the need to compress the timeline for products to be marketed and to decrease the cost associated with the build-out of a new facility or process, IQ and OQ documents have been massaged and varied in complexity and content. The IQ and OQ were also combined into a single-document format to save on paperwork as well as review and approval time. This new combination became known as the IOQ.