Calibration Management Guide Published by GAMP

GMP News No. 242

GMPNews
26 September 2002
 

Calibration Management GuidePublished by GAMP

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

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:

  • 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 arevery 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 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.


Author:
Harald Martin
CONCEPT HEIDELBERG
  

 

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