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Calibration Management
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The GAMP Good Practice Guide: Calibration Management is the first in a series of GAMP guidance on specific topics. Developed by the Calibration Management Special Interest Group (SIG) of ISPE's GAMP Forum in conjunction with representatives from the pharmaceutical industry and regulators, the Guide describes the principles of calibration and presents guidance in setting up a calibration management system, providing the structured approach required to establish formal criticality assessment, management, documentation, and corrective actions vital to regulatory compliance...
The GAMP Good Practice Guide: Calibration Management is the first in a series of GAMP guidance on specific topics. Developed by the Calibration Management Special Interest Group (SIG) of ISPE's GAMP Forum in conjunction with representatives from the pharmaceutical industry and regulators, the Guide describes the principles of calibration and presents guidance in setting up a calibration management system, providing the structured approach required to establish formal criticality assessment, management, documentation, and corrective actions vital to regulatory compliance. This Guide currently is available in English and German. It will be available in French in 2004.
Featured Topics
The Guide is structured to follow the life cycle of validation and is intended to cover initial calibration in addition to:
· periodic inspection, testing, and calibration
· laboratory instrumentation
· quality
· safety
· environmental issues
· regulatory requirements
Other volumes in the series will include:
· Legacy Systems
· Laboratory Computers Systems Validation
· Manufacturing Execution Systems
· IT Infrastructure
· Applications of GAMP to the Validation of Building Management Systems
Click here to visit the GAMP Good Practice Guide: Calibration Management
