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Article: Establishing a calibration management program
- Article from:
- Biopharm International
- Article date:
- May 1, 1998
- Author:
CopyrightCopyright Advanstar Communications, Inc. May 1998. Provided by ProQuest LLC. (Hide copyright information)
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Denise M. Evans and Jim Erickson
FDA's strict calibration requirements emphasize the importance of establishing a comprehensive calibration management program. Calibration functions generally fall under the production and manufacturing or quality assurance and quality control departments. For start-up biotech companies and companies with new calibration employees, developing and implementing this complex plan can seem daunting.
Before implementing a calibration management program, you must first identify its benefits. Predominant is the ability to ensure product consistency and quality. A thorough program minimizes the possibility of errors, from missed calibrations to out-of-calibration ...