Whether you are involved in manufacturing, transfer to manufacturing or R&D, if you work in a QC environment you’ve probably heard the terms IQ (installation qualification) and OQ (operational qualification). When a new piece of equipment or plant is being installed and commissioned for use, IQ and OQ are two independent and documented procedures used to check and test that a system is:
- Installed correctly
- Meets design specifications
- Operates the way it was designed to.
It’s a time consuming and expensive process, but necessary to ensure proper functioning of the system and importantly, meet the required quality assurance standards of validation and verification.
Installation Qualification is a documented process that verifies that all aspects of the equipment that affect product quality, meet the approved design specifications. It ensures that the instrument has been properly delivered, correctly installed and that is has been configured according to the manufacturer’s standards against an approved installation checklist.
Once the equipment has passed the IQ phase, the operational requirements, as well as the operational consistency of the equipment, must be put to the test. This is done through Operational Qualification, where each individual component or feature of the equipment is tested.
It’s not just new installations that need qualification testing. Re-qualifications provide documented verification that the instrument continues to operate as specified by the manufacturer. These are typically performed annually after an initial IQ/OQ has been completed, or according to the requirements of your standard operating procedures.
iLab Solutions offers IQ/OQ testing for new installations or re-qualifications of ÄKTA protein purification systems, such as Pure, Avant and Go as well older systems such as Pilot and Oligopilot. Our qualified and experienced field service engineers conduct comprehensive instrument testing using verified tests and certified tools to confirm instrument performance, leaving you with audit-style documentation so you can meet your regulatory requirements and industry standards.
Contact us to find out how iLab Solutions can provide a cost-effective validation and verification service for your new system installations as well as ongoing preventative maintenance (PM) service and repair.