Calibration verification document

Fit the purpose calibration. It is common sense to check instrument performance each day, and GLP requirements simply formalize the performance and documentation of these checks. On the other hand, it is also important to use the right test (full calibration, verification, system suitability test, or instrument and method validation) to verify the performance and to avoid needlessly lengthy procedures. As already discussed (see Sections 13.2.3 and 13.3.1), it is not always necessary to perform a MS full calibration every day. For example, if a particular MS is used only to record complete full-scan mass spectra, a daily calibration or verification of the calibration of the m/z ratio scale is required. However, in the case where a MS is coupled with an LC and utilized primarily for the analysis of one or more analytes in the selected ion monitoring (SIM) mode, it does not always require a daily verification of the calibration. In this specific case it is quite common in LC-MS and LC-MS/MS applications to test only the following performance parameters (a) sensitivity, (b) system precision,... 

OQ tests are very commonly used in the ongoing performance verification or calibration of the system. Test templates should be used for OQ. An example is shown in Figure 17.2. Most important is that acceptance criteria should be defined before the test, and both acceptance criteria and test results should be documented in the test sheet. 

Document of material specifications and test methods. Verification of the specifications must be done to satisfy the design, and the test method must be validated where needed. Because the material is a critical safety factor, the selection of material for IOL should meet both the physicochemical and compatibility specifications described in ISO 11979-2 and 11797-3. The in-house (receiving) specifications of material should thus be documented. Where a test method is developed, the method must be validated. The equipment used for the test must be calibrated. 

Installation qualification is documented verification that the computer system (including all required software) is installed satisfactorily and is compliant with appropriate engineering codes, manufacturer recommendations, and approved specifications, and that the instrumentation is calibrated and all services are available and of adequate quality. 

The laboratory should verify and document the proper functioning of the software immediately after any new data acquisition or management systems have been installed. The baseline verification consists of manual calculations to confirm the correctness of all computer calculations. Ongoing verification takes place during laboratory data review process whenever a reviewer replicates one of the results generated by the computer or a manual calculation from a bench sheet. All information used in the calculations (raw data, calibration data, laboratory QC checks, and blank results) is kept on file for the reconstruction of the final result at a later date, should it become necessary. Bench sheets that document sample preparation are also kept on file for the same purpose. 

Detailed review of reported data reduces laboratory risk of producing invalid data. Important features of internal data review are the spot checks of calculations the verification of the acceptability of calibrations and laboratory QC checks and the second opinion in data interpretation. Laboratories document internal review in appropriate checklist forms that are kept on file with the rest of the project documentation and sample data. The internal data review process is generally described in Laboratory QA Manual and detailed in appropriate SOPs. 

After installation and qualification the instrument requires regular maintenance and calibration. The instrument should be maintained on a preventive maintenance plan and calibrated periodically according to a documented schedule. The schedule for preventive maintenance and performance verification/recalibration will depend on the instrument, its environment, and its function. The proposed U.S.P. chapter on NIR spectrophotometry [6] suggests that The purpose of instrument qualification is to assure that an instrument is suitable for its intended application and, when requalified periodically, it continues to function properly over extended time periods. Performance verification includes a validation based on a quality of fit to an initial scan or group of scans included in the instrument qualification.. . . With such testing, it is expected that reference standard spectra collected on a new or newly repaired, properly operating instrument should be identical to spectra of those standards collected over... 

The documents must specify the procedure for servicing and maintenance including the intervals at which routine verification, adjustment or calibration are needed, and, where required, the principal break-down risks and possible corrective measures. A chronological list of the repairs carried out must specify their nature and cause. The documents must also include a copy of the service contract, if necessary. 

The performance of an instrument must be checked and appraised by a qualified person before being transported to the field. This involves a visual inspection and verification of its operation including the zero and full-scale calibration. Documents on... 

Certified reference materials (CRMs) are materials of known analyte concentrations with a similar matrix to the sample being analyzed that are certified by technically valid procedures accompanied by or traceable to a certificate or other documentation issued by a certifying body. CRMs play important roles in helping produce reliable results including calibration and verification of measurement processes, quality control, verification of standardized methods, and the development and validation of new methods. 

Association s (ISEA) Instruments Group has updated its guidelines for the calibration and verification of portable gas monitors which alert workers to the presence of toxic and otherwise hazardous gases. Originally published in 2002, the document gives employers and users uniform guidance on the frequency and types of tests and checks... 

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