45 IQ Installation qualification OQ Operational qualification PQ Performance qualification Installation qualification IQ is documented proof that testing de vices have been supplied and installed in line with the requirements prescribed in the design qualification and legal safety regulations The documentation for installation qualification consists of an IQ test plan and IQ report The scope of the installation qualification Inventory of the components delivered and check of the order documents Conformity check of the manufacturer s documentation nameplate delivery note Assembly test and review of correct installation on the basis of the layout plan if required Operational qualification OQ is a test process that evaluates whether the testing device functions correctly During the opera tional qualification all points specified in the test plan are checked and documented in writing In some circumstances otherwise only common for performance qualification PQ checks according to OQ can only be conducted with customer products Operational qualification must be passed for a testing device to be approved Operational qualification can only be carried out once installation qualification has been passed The documentation for operational qualification consists of an OQ test plan and OQ report Operational qualification involves identifying and monitor ing the following quality related alarm control and switch functions Initialisation of the testing device Weight adjustment and calibration Thickness adjustment and calibration Hardness breaking strength adjustment and calibration Diameter adjustment and calibration Length and width adjustment and calibration OZB adjustment and calibration Adjustment and calibration protocol Product setup Verification of test results Documented proof that operating personnel have been trained Performance qualification PQ is a key part of validation of the entire production process over a certain period of time and for a specific product It proves and documents that testing devices work within the specified limit values The testing devices are not exam ined separately but always as part of the entire process Although PQ generally includes the OQ tests under process conditions it is essential that a detailed test plan is drawn up on the basis of a thorough process description before the beginning of the validation process Performance qualification comprises Documentation under process conditions outlining that the testing device or the entire process with the product results in the expected defined results The scope of the PQ can result from the operator s specifications or normative and legal requirements Documentation of the process and results in the qualification report Validation through multiple repetition reproduction of processes often three times in pharmaceutical medical technology Service

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