IQ, OQ, and PQ are terms you have most likely come across or heard your development and manufacturing partner talk about if you work in the medical device business. But what do they actually mean? And why are they so important in medical device manufacturing? Let me sort it out for you.

What are IQ, OQ, and PQ?

IQ, OQ, and PQ are sequential activities that manufacturers carry out to validate their manufacturing processes. IQ stands for Installation Qualification, OQ for Operational Qualification, and PQ for Performance Qualification. The purpose of process validation is to establish documented evidence that the production equipment is correctly installed, operates according to requirements, and performs safely. It is also to demonstrate that the manufacturing process under normal operating conditions will consistently produce conforming products.

The ideal way to ensure the quality of medical devices

In each phase of the validation process, documents are compiled with detailed results of each qualification test. After performing IQ, OQ, and PQ successfully with the desired result and established documents that verify each phase, a manufacturing process can get underway. The defined discipline for a validation process has proven to be the ideal way to guarantee the best quality of medical devices consistently over time.

Which manufacturing processes must be validated?

Any medical device manufacturing processes where the result is not verifiable by subsequent monitoring or measurement must be validated. A validation plan should be established including the steps of IQ, OQ, and PQ for each process. The approach should be risk-based to ensure critical parameters or specifications are adequately taken care of.

IQ validates that equipment is correctly installed

IQ is the first step in the validation process. In this phase, you verify that the manufacturing equipment meets the design specifications and has been correctly installed and configured according to requirements. You need to confirm that all necessary documents, drawings, and manuals are correctly executed and available. During IQ, equipment maintenance as well as calibration schedules and procedures should be established.

OQ validates that equipment operates as intended

OQ is the second step in the validation process. In this phase, you verify that the manufacturing equipment operates according to requirements. You need to carry out tests for each component to confirm that every part of the manufacturing equipment operates as intended at pre-set thresholds. By challenging the manufacturing process using “worst-case” conditions, it is possible to determine your process window and to ensure a   reproducible manufacturing process resulting in conforming products.

PQ validates process stability over time

PQ is the third and last step of the validation process. In this phase, you verify process stability over time by running the equipment several times with a load under normal operating conditions to challenge its functionality and safety. This will demonstrate if the process will produce a product that conforms to its requirements.

Why are IQ, OQ, and PQ so important in medical device manufacturing?

Medical devices are intended to be used for humans and need to meet regulatory requirements. IQ, OQ, and PQ are important steps in a validation process to prove that the medical devices meet all predetermined requirements for functionality and safety, as well as the regulatory standards. Non-conforming products could lead to human injury and result in costly product recalls. A well-planned and performed validation process is crucial for manufacturers to ensure that they have a controlled manufacturing process that consistently produces conforming products that ensure the quality and safety of the medical device.

How are IQ, OQ, and PQ carried out correctly?

IQ, OQ, and PQ should be carried out by the manufacturer according to the FDA and ISO standards. Read more about these standards and the tasks associated with IQ, OQ, and PQ validation in the links below. Also, the GHTF (Global Harmonization Task Force) provides guidance that clarifies how to act. (The guide is an internationally harmonized document recognized by both the FDA and ISO).

●  FDA Quality System Regulation (21 CRF Part 820)

●  ISO 13485: 2016 Medical Devices – Quality Management System

●  GHTF Quality Management Systems – Process Validation Guidance (GHTF/SG3/N99-10:2004 Edition 2)