The installation qualification (IQ) checks that devices and systems are installed correctly in the GxP environment before commissioning.
Installation qualification (IQ) is essential to the GxP environment, especially in regulated industries such as the pharmaceutical, biotechnology and medical device industries. It ensures that all installation and configuration requirements for devices, equipment and systems are adequately met before they are put into operation.
During IQ, all aspects of the installation are checked, including the physical installation, electrical connections, software installation and other specific requirements. This ensures that the equipment and systems are installed correctly and function properly.
IQ documentation typically includes logs, checklists, and test reports that document the installation steps performed, the test results, and any deviations or problems. This documentation is crucial for traceability and fulfilling regulatory requirements.
A thorough installation qualification ensures that the devices and systems perform as required and that product quality, safety, and effectiveness are guaranteed. It forms the basis for further qualification activities such as Operational Qualification (OQ) and Performance Qualification (PQ), helping to ensure compliance with GxP regulations and product quality.
