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GAMP Good Praclice Guide

ARisk-Based
Approach to Calibration
Management
Second Edition

Disclaimer:
This Guide is meant to assist pharmaceutical companies in managing calibration. The GAMP COP Calibration
Special Interest Group cannot ensure and does not warrant that a system managed in aceordanee with this Guide
will be acceptable to regulatory authorities. Further, this Guide does not replaee the need for hiring professional
engineers or technicians.
Limitation of Liability
In no event shall ISPE or any of its affiliates, or the officers, directors, employees, members, or agents of each
of them, be liable for any damages of any kind, inc/uding without limitation any special, incidental, indirect, or
consequential damages, whether or not advised of the possibility of such damages, and on any theory of liability
whatsoever, arising out of or in connection with the use of this information.

Copyright ISPE 2010. All rights reserved.

All rights reserved. No part of this document may be reproduced or copied in any form or by any means - graphie,
electronic, or mechanical, including photocopying, taping, or information storage and retrieval systems - without
written permission of ISPE.
All trademarks used are acknowledged.
ISBN 978-1-931879-99-6

GAMp Good Practice Guide:

A Risk-Based Approach to Calibration Management

Page 5

lable 01 Contents
1

Introduction ......................................................................................................................... 7
1.1
1.2
1.3
1.4
1.5
1.6
1.7

Rationale ...................................................................................................................................................... 7
New and Revised Material ........................................................................................................................... 8
Purpose ........................................................................................................................................................ 9
Scope ......................................................................................................................................................... 10
Regulatory Requirements ................................................................................... ,...................................... 11
Business Benefits ...................................................................................................................................... 11
Structure .................................................................................................................................................... 11

Key Concepts and Terms ................................................................................................. 13

2.1
2.2

Key Concepts ............................................................................................................................................. 13

Key Terms .................................................................................................................................................. 13

Key Roles and Responsibilities ...................................................................................... 17

Instrumentation Life Cycle Approach ............................................................................. 19

Common Practices ........................................................................................................... 21

5.1
5.2
5.3
5.4
5.5

Project Phase ... ................................................................................................................. 41

6.1
6.2
6.3
6.4
6.5
6.6

Roles and Responsibilities in the Project Phase ........................................................................................ 43

Instrument Tagging/ldentification ............................................................................................................... 44
Instrument Selection .................................................................................................................................. 45
Automation and Smart Instrumentation .................................................. ,.................................................. 49
Supplier Selection ...................................................................................................................................... 50
Instrument Verification ............................................................................................................................... 51

Operation Phase ............................................................................................................... 53

7.1
7.2
7.3
7.4
7.5
7.6
7.7
7.8

Criticality Risk Assessment ........................................................................................................................ 21

Change Management ................................................................................................................................ 28
Calibration Management Software ............................................................................................................. 30
Auditing ...................................................................................................................................................... 31
Measurement Capability and the Potential Influence of Measurement Uncertainty .................................. 34

Roles and Responsibilities in the Project Phase ........................................................................................ 54

Calibration Documentation ......................................................................................................................... 55
Calibration Methodology ............................................................................................................................ 58
Calibration Process .................................................................................................................................... 60
Training ...................................................................................................................................................... 62
Management of Third Party Calibration ..................................................................................................... 63
Calibration Non-Conformance ................................................................................................................... 64
Decommissioning of Instruments ............................................................................................................... 66

Laboratory and Analytical Equipment ............................................................................ 69

GAMp Good Practice Guide:

A Risk-Based Approach to Calibration Management

Other Considerations ....................................................................................................... 71

9.1
9.2
9.3
9.4
9.5

Fieldbus ..................................................................................................................................................... 71
Auto Calibration ......................................................................................................................................... 71
On-Line Alerts ............................................................................................................................................ 72
Self Documenting Calibrators/Asset Management Systems ..................................................................... 72
Process Analytical Technology ................................................................................................................... 72

10

Appendix 1 - Worked Example Showing Tolerance ...................................................... 75

11

Appendix 2 - Measurement Uncertainty Calculation - Examples ............................... 81

12

Appendix 3 - Calibration Management Software ........................................................... 85

12.1 User Requirements Specification ............................................................................................................... 85

13

Appendix 4 - Instrument Tagging Process .................................................................... 91

14

Appendix 5 -Indicative Regulatory Requirements ....................................................... 99

15

Appendix 6 - List of Attachments ................................................................................. 105

16

Appendix 7 - References ............................................................................................... 107

16.1 References ............................................................................................................................................... 107
16.2 Further Reading ....................................................................................................................................... 108

17

Appendix 8 - Glossary ................................................................................................... 109

17.1 Abbreviations and Acronyms ................................................................................................................... 109
17.2 Definitions ................................................................................................................................................ 110