After verifying that all equipment/systems are installed correctly (Installation Qualification phase - IQ), it is necessary to complete tests to confirm whether everything operates according to the specified requirements.
The qualification step performed after the IQ phase is Operational Qualification – OQ.
Operational Qualification (OQ) is aimed at obtaining a final confirmation of production equipment/systems performance before they are accepted as fully commissioned and operational.
At the Operational Qualification (OQ) step this is the documented confirmation that equipment, utilities, complete clean rooms performance complies with the requirements of regulatory and technical documentation.
This step includes verification and evaluation of equipment, utilities, complete clean rooms performance by means of testing their functions and parameters using measuring instruments, if required.
In the course of OQ phase it is important to prove the following:
- all checked operational functions comply with the acceptance criteria;
- equipment/systems run correctly and reliably under normal and worst possible conditions.
The Operational Qualification (OQ) step determines the critical parameters of equipment/system. This is necessary to test equipment performance in the conditions of the worst possible scenario that is critical to the process and product quality.
In case of complex or bulky equipment it is allowed to perform acceptance at the supplier's assembly site; however, it does not replace the OQ phase that is completed at the production site.
Operational Qualification (OQ) phase also includes clarification of standard operational procedures designed in the IQ phase.
If errors are identified in the process of Operational Qualification (OQ), it is absolutely necessary to record the errors and analyze their possible causes, assess risk level and work out the procedure for further corrective actions and their completion dates.
If the presence of errors affects completion of Performance Qualification (PQ), the OQ step is considered as failed or not accepted.
It is mandatory to eliminate the errors; then the tests and qualification are repeated.
Each qualification step, including Operational Qualification (OQ) is substantiated with the documented confirmation of correct equipment operation.
OQ qualification results are reflected in appropriate protocols and an Operational Qualification (OQ) report is drawn up.
After the Operational Qualification (OQ) a documented permit for moving to the next step is issued: either to the qualification of performance properties or to process validation.
