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GMP News No. 242
26 September 2002
Calibration Management GuidePublished by GAMP
The GAMP Good Practice Guide "Calibration Management"describes a calibration management system that defines what needs to bedone, when, by whom, and why. This Guide also describes the fundamentalprinciples and suggests a prioritised, effective method for meeting thecalibration needs of the pharmaceutical industry and satisfying therequirements of the regulators.
This Guide gives general guidance as well as examples of documentationand working methods.
In the following we have listed the chapter headings of the new Guideto get an overview of the content:
At the end of general guide you can find several appendices, which arevery helpful in the daily work.
The document is structured to follow the life cycle of validation andis intended to cover initial calibration as well as periodic inspection,testing and calibration. The Guide does not cover the detail of testmethodology but concentrates on calibration management.
The GAMP Good Practice Guide "Calibration Management" isintended for use by engineers, Quality Assurance (QA), and personnelinvolved in the management of calibration in a regulated environment.