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.

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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