Calibration Management Guide Published by GAMP

GMP News No. 242

GMP News
26 September 2002
 

Calibration Management Guide Published by GAMP

 
At the beginning of 2002, ISPE published a new GAMP Good Practice Guide on Calibration Management.

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:

  • Introduction
  • Objective
  • Scope
  • Key Definitions and Responsibilities
  • Key Regulatory Requirements
  • Criticality Assessment
  • Life Cycle Phases
  • Project Phase
  • Training
  • Change Control
  • Documentation
  • Electronic Records
  • Auditing
  • Other Considerations
  • Calibration Management Software
  • Smart Calibrators and Test Equipment
  • References
  • Glossary

At the end of general guide you can find several appendices, which are very helpful in the daily work.

  • Worked Example Showing Calibration Failure Limits
  • Example Calibration Master List
  • Example Declaration of Decontamination Status
  • Example Non-Conformance Report
  • Example Calibration Certificate
  • Example Standard Operating Procedure: Calibration By Work Order
  • Example Calibration Report Standard Operating Procedure
  • Example Calibration Work Instruction Standard Operating Procedure

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:

Author:
Harald Martin
CONCEPT HEIDELBERG
  

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