Operational qualification (OQ) is the documented proof that facilities, systems and plants, as installed or modified, function as intended throughout the anticipated operating ranges.
Definitions of operational qualification
Aide Memoire GMP
“Documented proof that the facilities, systems and plants, as installed or modified, function properly throughout the anticipated operating range.”
EU GMP Guide, Annex 15
“The documented verification that the facilities, systems and equipment, as installed or modified, perform as intended throughout the anticipated operating ranges.”
Contents of the OQ
Prerequisite: The IQ has been completed successfully. The OQ then checks whether the function of the technical system matches the functionalities required in the requirement specification.
Planning & documentation
- plan for carrying out the OQ
- test reports for the individual functional tests
- creating a logbook
- review of the supplier’s technical documentation
- completeness check
- report on the execution of the OQ
Functional tests
- checking the individual functions
- identifying and checking quality-relevant functions
- checking the performance parameters
- checking the ambient conditions
- checking electromagnetic compatibility
- reviewing the risk analysis
Calibration & operation
- calibration of measuring points and definition of calibration intervals
- work instructions supplementing the operating manuals
- adapting work instructions for calibration and maintenance
The qualification process at a glance
- 1RA – Risk analysisIdentify and assess risks before the design is fixed.
- 2DQ – Design qualificationProof that the design is suitable for the intended purpose.
- 3IQ – Installation qualificationVerification of the installation against the order documents.
- 4OQ – Operational qualification (this page)Verification of the intended functionality.
- 5PQ – Performance qualificationProof of the required performance in operation.
SEEFRIED Verfahrenstechnik GmbH supports you with preparing the documentation and verifying the operational qualification.
Frequently Asked Questions about operational qualification (OQ)
What is operational qualification (OQ)?
OQ is the documented verification that facilities, systems and equipment, as installed, operate as expected throughout the intended operating ranges (EU GMP Guidelines, Annex 15).
What is the prerequisite for the OQ?
The installation qualification (IQ) must have been completed successfully.
What is checked during OQ?
Whether the plant functions meet the functionalities defined in the requirement specification – including individual functions, quality-relevant functions, performance parameters, ambient conditions, calibration of measuring points and electromagnetic compatibility.
Which documents are produced in the OQ?
OQ plan, test reports, calibration intervals, work instructions for operation, calibration and maintenance, a logbook and a final OQ report.