Do you get confused with medical terminology that sometimes sounds like mumbo jumbo? You are not alone! What do these abbreviations actually mean? This is something that everyone working with manufacturing or production in the medtech industry needs to know. I will guide you through it.
A process to fulfill US regulations and ISO
Regulations and ISO standards applicable for medical devices require that validation of a manufacturing process shall be performed. In fact, both the U.S. Quality System Regulation 21 CFR Part 820 and ISO 13485:2012 have explicit elements requiring the manufacturer to perform tasks associated with IQ’s, OQ’s and PQ’s, Note that these explicit terms are not found in either the regulations nor the ISO standard, but the requirements are clearly stated. A GHTF guidance, which is an internationally harmonized document recognized by both the US FDA and ISO clarifies how to act*.
The purpose is to establish documented evidence that all necessary production equipment are present, connected to appropriate utilities and are performing according to the approved specifications, and to demonstrate that the process under normal operating conditions will consistently produce products in compliance with product specifications.
There is a need to validate every manufacturing process for production of medical devices where the result is not verifiable by subsequent monitoring or measurement. For each manufacturing process, a validation plan shall be established. The validation plan shall define the validation approach for the manufacturing process in relation to the IQ/OQ/PQ elements. The approach should be risk based to secure that the critical product parameters or specifications are adequately taken care of.
Installation is key for manufacturing equipment to deliver a desirable result
IQ stands for Installation Qualification. This is the first step in the validation process to ensure that the manufacturing process will live up to its expectations. In this phase you verify the equipment’s design features and make sure it was installed correctly. Often the basis for IQ is the design specification with the installation requirements. Therefore it is of high importance to verify that all necessary documents, drawings and manuals are available. During installation qualification, equipment maintenance and calibration schedules and procedures should be established. Equipment should be calibrated before and after process validation to determine whether the equipment remained in calibration during the entire process validation study.
Test runs determine the operational qualifications
OQ stands for Operational Qualification. In this phase you want to verify that the manufacturing process is achieving its operational requirements. Test runs will determine the highest, lowest and medium operating parameters. You will use the process parameters to set control limits and action limits. They help you ensure the process is reproducible. You will “challenge” the process by using “worst case” conditions. If the Operational Qualification is successful, it validates that process control limits and action levels result in product that meets all predetermined requirements.
Functions will be challenged under normal conditions
PQ stands for Performance Qualification and is the last phase of the validation process. Here, the equipment will run several times under normal operating conditions and its functions will be challenged. The purpose with the PQ is to demonstrate that the process, under anticipated conditions, consistently (long term runs) produces a product which meets all predetermined requirements for functionality and safety.
IQ, OQ, PQ the ideal way to guarantee absolute quality of medical devices
In each phase of the process, documents are compiled with detailed results of each qualification test and a judgement if defined acceptance criteria were met. Only after performing IQ, OQ, PQ successfully with a desired result and established documents that verify each phase, the production can get underway. This defined discipline for process validation has proven to be the ideal way to guarantee the best quality of products, constantly over time.
Validation process to prevent human injury and product recall
A well planned and performed process validation is an important work to ensure that you have a well-controlled manufacturing process consistently producing conforming products. Non-conforming products could lead to human injury or result in costly product recalls. By implementing a successful validation process, medical device manufacturers can improve productivity, reduce recalls and consumer complaints and also reduce the burdensome process of investigations.
Do you want to learn more about IQ, OQ, PQ? Don’t hesitate to contact me. Please stay tuned for more interesting articles and topics on our Medtech Blog.
*GHTF/SG3/N99-10:2004 (Edition 2), Quality Management Systems – Process Validation Guidance
