(1999; 168 pages) [Spanish]
7.3.7 Calibration of measuring and test equipment
All measuring and test equipment identified as being part of the quality system should be properly calibrated and maintained. This includes all in-process instruments identified as critical quality instruments, as well as test equipment used in the laboratory. The control programme should include the standardization or calibration of reagents, instruments, apparatus, gauges and recording devices at suitable intervals, in accordance with an established written programme containing specific directions, schedules, limits for accuracy and precision, and provisions for remedial action in the event that accuracy and/or precision limits are not met. Reagents, instruments, apparatus, gauges and recording devices not meeting established specifications should not be used. Computer systems used to verify that the product conforms to specifications must be audited to ensure satisfactory performance in the laboratory.