You might have heard the terms IQ OQ PQ, but do you know what they mean and why do these processes exist? In this article we will explain a little more as well as discuss why the order is always IQ then OQ then PQ.
Development & manufacturing processes in the pharmaceutical and biotechnology sectors are used for or consumed by humans which therefore must meet regulatory requirements. IQ, OQ, and PQ are important steps in the validation process to prove that the manufacture or process meet all predetermined requirements for functionality and safety, as well as any necessary regulatory standards. Non-conforming or incorrectly manufactured products could lead to human injury or death and result in costly product recalls and litigation. A well-planned, risk-based, validation process is crucial for manufacturers to ensure that they have a precisely controlled process that provides consistency where products are made, or processes performed. Any deviations to the process are captured and ultimately personnel alerted before the product or process continues.
IQ stands for Installation Qualification, OQ for Operational Qualification, and PQ for Performance Qualification and is a sequential set of activities that take place to establish documented evidence that the equipment or process is installed, operates, and performs according to requirements. For each phase of the IQ OQ PQ validation process, pre-approved documents are compiled with detailed results of each qualification test. The documentation for each qualification must be scrutinised and approved before the subsequent qualification can be performed
After performing IQ, OQ, and PQ successfully, with the desired result and established documented evidence, verification is complete that ensures each phase the equipment or process installed can now enter the manufacturing process.IQ is the first step in the validation process. In this phase, you will verify that the manufacturing equipment meets the design specifications and has been correctly installed and configured according to requirements. Here all relevant documents, drawings, and manuals are present for inspection. Documents will be archived and the location that they are stored will be referenced for any retrieval after the validation exercise is complete. Calibration certificates and maintenance schedules also form part of the IQ.
Once the IQ has been scrutinised and signed off, OQ is the second step in the validation process. In this phase, you verify that the manufacturing equipment or process performs according to system design. Tests that prove every aspect and possible outcome of the system or process are executed using the designed manufacturing process thresholds.
Following on- 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 conforms to its requirements.
Records of all validation activities will be retained and signed off by key stake holders across the organisation. Engineers at Withnell Sensors are routinely involved in executing IQ/OQ/PQ activities for the range of equipment that we supply. Alternatively, documentation can be supplied that allows on-site engineers to complete the necessary validation. Our engineers are routinely involved in IQ/OQ/PQ activities for the equipment that we supply. If you have any questions about any aspect of the qualification of your equipment, then do not hesitate to speak to one of our team.