Preventative maintenance, instrument quality

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... 

All instrumentation within aseptic manufacturing facilities should be identified during validation, and the potential of each instrument for causing deleterious effects to sterility should be independently evaluated. All instruments should be calibrated and scheduled for routine recalibration and for routine preventative maintenance. A system should be set up to ensure that any failure to meet these predetermined schedules is flagged to Quality Assurance to evaluate the effect on sterility. 

Each laboratory should have a quality assurance program which should be well understood and used by individuals as well as by laboratory organizations to prevent, detect, and correct problems. The purpose is to ensure that the results have a high probability of being of acceptable quality. Ongoing activities may include preventative instrument maintenance, performance verification and calibration, system suitability testing, analysis of blanks and quality control samples, and ensuring system security. A plan should be set up to... 

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