Equipment qualification is the process of verifying and documenting that equipment, facilities, and systems are suitable for their intended use and operate consistently within their specified range of parameters. It is an important aspect of ensuring product quality and regulatory compliance in various industries such as pharmaceuticals, biotechnology, medical devices, and food manufacturing.
The equipment qualification process typically includes several stages, such as design qualification (DQ), installation qualification (IQ), operational qualification (OQ), and performance qualification (PQ). DQ ensures that the equipment design meets the intended use and regulatory requirements, IQ verifies that the equipment is installed correctly, OQ tests the equipment’s functionality and performance under normal operating conditions, and PQ verifies that the equipment consistently operates within its specified range of parameters.
Equipment qualification also includes documentation of all activities, testing, and results, as well as periodic requalification to ensure ongoing compliance. It is important to have a well-documented and well-executed equipment qualification process to ensure product quality, reduce risks, and meet regulatory requirements.