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:
