GMP News No. 242
26 September 2002
Calibration Management Guide Published by GAMP
The GAMP Good Practice Guide "Calibration Management" describes a calibration management system that defines what needs to be done, when, by whom, and why. This Guide also describes the fundamental principles and suggests a prioritised, effective method for meeting the calibration needs of the pharmaceutical industry and satisfying the requirements of the regulators.
This Guide gives general guidance as well as examples of documentation and working methods.
In the following we have listed the chapter headings of the new Guide to get an overview of the content:
At the end of general guide you can find several appendices, which are very helpful in the daily work.
The document is structured to follow the life cycle of validation and is intended to cover initial calibration as well as periodic inspection, testing and calibration. The Guide does not cover the detail of test methodology but concentrates on calibration management.
The GAMP Good Practice Guide "Calibration Management" is intended for use by engineers, Quality Assurance (QA), and personnel involved in the management of calibration in a regulated environment.
On the topic of "Calibration Management", we are organising the following event: