Operational Qualification

Operational Qualification (OQ) has to be performed after satisfactory completion of the system/equipment Installation Qualification execution.

The OQ describes the operational tests, measurements, and control tolerances of key parameters that are critical for the proper operation of the system. Test objectives, methodologies, and acceptance criteria should be defined in OQ protocol.

Execution of the OQ involves the testing and measuring of system’s key operational parameters. This activity includes monitoring and evaluating operational data obtained from instruments, indicators, gauges and sensors.

Any “worse case” challenges to the system/equipment are defined and incorporated into the testing strategy to challenge the system/equipment capacity. The OQ includes a review of the SOPs for start-up, operation, maintenance, safety, and cleaning/sanitization if applicable. Calibration information for control, monitoring, and recording instrumentation (e.g., pressure gauges, temperature sensors, timers, etc.) that could impact product integrity, quality, or efficacy will be reviewed.

All critical process instrumentation is calibrated prior the Operation Qualification execution and must remain in calibrated state during the protocol execution. Process and monitoring equipment (instruments) are calibrated at the beginning of the validation study, and if process instrumentation has been used to gather the qualification data, the calibration should be checked at the end of the study to establish confidence in qualification. Equipment found out of calibration at the end of a process validation study may indicate that the process has not been operating in a state of control and cannot be considered validated.

Any exceptional conditions encountered during the OQ will be identified, investigated, and documented (including justification, correction, and any necessary re-qualification studies).

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