GXP

cGMP Equipment, Instruments, and Calibration | IVT

INTRODUCTION After the equipment at a site has been qualified, and that qualification has included the calibration of the instruments and controls maintaining the process, a site must maintain its calibration program. Just as with maintenance considerations, the second law of thermodynamics states that an instrument will naturally gravitate to a state of greater disorder and inaccuracy. As soon as the validation effort is complete and the equipment put to use, instruments start wearing out. Instruments start moving toward a state different than when they were originally qualified. All instruments...

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