Device qualification

Device qualification

Safe installation and qualification

Good Manufacturing Practices (GMP) are guidelines and standards used in the pharmaceutical industry to ensure that medicines and medical devices are manufactured safely and to a high quality. Compliance with GMP ensures that production processes are controlled, documented and validated. Equipment qualification plays an important role in these requirements.

We attach great importance to the qualification of our code verification devices used in the production line. We work closely with our customers to support the installation and qualification of our REA VERIFIER devices.

Functional tests and physical measurements

Installation qualification IQ

The installation qualification IQ is the documented proof that the REA VERIFIER devices have been delivered and installed in accordance with the requirements specified in the design qualification (DQ). The design qualification has already been carried out before commissioning. The suitability of the device system and the supplier was verified. The order was then placed and the device delivered. The assembly and installation of the analysis system is carried out by the operator and, if necessary, by the manufacturer / supplier. Proof of the completeness and functionality of the device hardware and software is ensured by functional tests and physical measurements.

IQ test plan: Contains detailed test steps for the inspections to be carried out on the respective device as part of the installation qualification IQ as well as necessary requirements and documents to be included.

IQ report: Once the IQ installation qualification has been completed, the results are summarized, evaluated and recorded in a final IQ report. All deviations and the measures taken to rectify them are documented.

The scope of the IQ installation qualification:

• Verify that the delivery is complete
• Verify that the delivered devices function perfectly
• Verify the measurement accuracy - initial
• Verify that the system requirements have been met
• Verify whether quality specifications have been implemented as device settings / profiles of the device settings
• Verify that the measurements are logged according to specifications and, if necessary, verify that the test reports are protected against changes and deletions

Commissioning of the testing technology

Operational qualification OQ

The operational qualification OQ is the commissioning of the testing technology in the interaction of the device hardware and measuring method, including proof that all customer-specific specifications are available and covered by the device configuration. The user determines who is responsible for the device technology. Training of the operating personnel is carried out independently by the user, externally by the supplier or both. Operational qualification can only be carried out after successful IQ installation qualification.

OQ test plan: Contains detailed test steps on the inspections to be carried out on the respective device in connection with the operation qualification OQ as well as necessary requirements and documents to be included.

OQ report: Once the OQ operational qualification has been completed, the results are summarized, evaluated and recorded in a final OQ report. All deviations and the measures taken to eliminate them are documented.

The scope of the operational qualification OQ:

• Commissioning
• Creating system requirements
• Training

Regular inspection

Performance qualification PQ

Performance qualification prints the regular inspection of the device function during routine operation. For this purpose, a monitoring strategy is defined to ensure the functionality of the analyzer system. This includes carrying out and documenting regular checks of the measuring accuracy in the sense of test equipment monitoring (calibration). The test system is adjusted in accordance with the manufacturer's specifications. The test data has to be recorded as documented proof. Regular preventive maintenance work must be carried out by the user and maintenance work must be arranged by the manufacturer as required. The user has to check the validity of the calibration card and verify whether it is damaged.

The PQ performance qualification includes

• Continuous checking of correct device function
• Regular check of the correct setting
• Regular check of the measurement accuracy
• Regularly checking whether there are changed or additional quality specifications
• Regularly checking whether additional or changed quality specifications have been adopted in the device settings
• Verify that test reports are stored/saved correctly