SYMPOSIA PAPER Published: 01 January 1996

Staying in Control — Ongoing Calibration and Change Control Practices


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.

Author Information

Busfield, JT
Pharmaceutical Technical Services, Warrington, PA
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Developed by Committee: E48
Pages: 136–152
DOI: 10.1520/STP14716S
ISBN-EB: 978-0-8031-5322-6
ISBN-13: 978-0-8031-2405-9