GAMP Good Practice Guide: Calibration Management

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.

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

Published:

12/01/2001

ISBN(s):

1931879257

Number of Pages:

56