Quality Management System for Active pharmaceutical

Quality Management System - integrating GMP into ISOChapter 11: Control of inspection, measuring and test equipmentPrincipleWhile all equipment (including relevant software) should be properly controlled and suitablymaintained, instruments used to make quality critical measurements should be regularlycalibrated against a recognised, traceable standard.11.1 Selection of equipment should be based upon a consideration of the type ofmeasurement, the required accuracy, and the capability (accuracy and precision) ofthe available equipment.11.2 Equipment and its calibration status should be clearly identifiable.11.3 Equipment should be calibrated by a competent person against, and traceable to, anational or international standard whenever possible. When no such standard exists,the basis for calibration should be clearly documented.11.4 Equipment should be recalibrated in accordance with a predetermined schedule, andusing an approved documented procedure. The frequency of recalibration may varyfrom one piece of equipment to another. It should initially reflect the equipmentmanufacturer’s recommendation but, as experience is gained, the extent andfrequency of recalibration may need to be adjusted to ensure consistent optimumperformance. Any changes in calibration frequency should be justified by previouscalibration records.11.5 Use, calibration, repairs, and maintenance of quality critical inspection, measuringand test equipment, should be recorded, and these records (including calibrationcertificates) maintained for a prescribed period of time.11.6 Deviations from approved standards of equipment maintenance should beinvestigated to determine if they could have an impact upon product quality.11.7 If equipment is found to be out of calibration it should be identified as such and, ifpossible, physically removed to prevent inadvertent use until it can be checked,recalibrated, and deemed suitable for use again. The validity of the equipment’s usesince it was last known to be performing satisfactorily (i.e. last calibrated) shouldalso be investigated.38