Operational qualification (OQ; German: Funktionsqualifizierung) is used to prove that the individual components of an installation or system function as specified in all intended operating modes. Certain tests are carried out to check whether the function of the system corresponds to the functions of all equipment components specified in advance in the user requirements specification and/or the functional specification.

Operational qualification should include the following elements:

• Test in operation: Involves checking whether the devices and systems function properly in all intended operating modes.
• User requirements specification and/or functional specification: Checking whether all components (German translation: Bestandteile) of the system meet the required specifications.
• Deviation analysis: Evaluation and correction of deviations (German: Abweichungen) from normal operation.
• Documentation: Thorough documentation of all test and inspection phases, including preparation of a report on the completed operational qualification.

Successful completion of the operational qualification is necessary for the completion of calibration, operating and cleaning instructions, operator training and the definition of preventive maintenance requirements.

Operational qualification ensures that installed equipment and systems function reliably in accordance with the specifications and requirements defined in advance. This is important in order to ensure the accuracy, reliability and repeatability (translation into German: Wiederholbarkeit) of drug manufacturing processes.

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