GAMP Good Practice Guide: A Risk-Based Approach to Calibration Management, Second Edition

Posted on: 09/12/202012/21/2019
Posted by: admin
Posted in: ISPE

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The GAMP Good Practice Guide: A Risk-Based Approach to Calibration Management (Second Edition) provides guidance in setting up a calibration management system, which will give a structured approach to instrument risk assessment, calibration program management, documentation, and corrective actions, essential to regulatory compliance. The Guide has been updated to address the changing environment, while still satisfying international GxP regulatory expectations.

The Guide has been updated to address the changing environment, while still satisfying international GxP regulatory expectations, current at time of publication. The scope has been widened to include related industries, laboratory, and analytical instrumentation.