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All regulated drug companies-pharmaceutical, medical device, and biopharmaceutical-dedicate considerable resources to the validation effort involved in starting a new facility or process. This effort is aimed at insuring that the process is under control. However, this state of control would be short-lived if not actively and rigorously maintained. Two programs essential to maintaining a process in a state of control are the Calibration and Change Control programs. A Calibration Program involves controlling the accuracy of the instruments that control the process. If the calibration of this equipment is not controlled, the process cannot be in control. A Change Control Program is the insurance that the effort spent in initially validating equipment and processes is not voided by an ill-conceived change to the equipment or process. The program provides that any change must be reviewed by appropriate personnel, its impact evaluated, the requirement to revalidate and/or the extent of revalidation examined, and the documentation of the changes maintained.
calibration, change, change control, control, validation, instruments, metrology, process control, regulations, re-validation
Owner, Pharmaceutical Technical Services, Warrington, PA