What Are IQ, OQ and PQ?
IQ, OQ and PQ are core elements in the process validation framework to mitigate risks associated with equipment failure. They are sequential steps that collectively validate the equipment and processes used in manufacturing, ensuring they consistently produce high-quality products.
Each of these three essential stages of process validation ensures that all equipment functions as intended - every single time. Each stage ensures that the entire manufacturing process is robust and reliable by validating different aspects of the equipment and associated processes.
The 3 Steps to Process Validation
Installation Qualification Tests (IQ)
Installation Qualification is the first step in the validation process. This phase verifies that all equipment, systems, and instrumentation are installed according to the manufacturer's specifications. It involves checking the installation against technical specifications and user requirements and ensuring that all documentation is in order. Proper execution of IQ is foundational for the subsequent validation stages.
Operational Qualification Tests (OQ)
Operational Qualification is the second stage, where the equipment undergoes rigorous testing to determine its functionality under expected operating conditions. This phase identifies and establishes process control limits, potential failure modes, and worst-case scenarios. The goal is to ensure that the equipment operates as required and can handle variations in the process while maintaining consistent performance.
Performance Qualification Tests (PQ)
Performance Qualification is the final stage of process validation, aiming to demonstrate that the equipment and processes consistently produce acceptable results during normal operations. PQ tests the equipment's performance in a real-world production environment, confirming its ability to meet established performance criteria and deliver consistent, high-quality products over a specified timeframe.
Importance of IQ, OQ and PQ in Process Validation
The implementation of Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ) is essential for companies in the pharmaceutical sector to reduce the risks associated with equipment failure and the associated consequences for the final product.
To meet these standards, manufacturers must carefully complete and document all three stages. Each stage focuses on validating different aspects of the equipment and its associated processes, ensuring the entire manufacturing process is robust and reliable. The sequence of these stages - first IQ, then OQ, and finally PQ—is crucial.
This structured approach ensures that each phase builds on the previous one, facilitating compliance with regulatory standards, safeguarding product quality, and enhancing patient safety. Additionally, these documents are subject to regular audits by the authorities to ensure their accuracy, completeness, and compliance with applicable laws.
