Contents of GAMP 5 CD
Copyright in the whole and every part of this material is owned by ISPE. No reproduction for commercial
purposes, resale, or other commercial use of the whole or any part of this material is allowed without the written
agreement of ISPE.
Where indicated, purchasers of GAMP 5 are free to use and modify this material for internal use within their
organization only. The material is indicative only and intended to be neither exhaustive nor prescriptive.
The CD consists of:
1.
2.
3.
4.
5.
6.
Figures from the GAMP 5 Main Body and Appendix M3*
Example Forms and Templates**
Example Checklists and Questionnaires**
GAMP 4 to GAMP 5 Summary
Historical Acknowledgements including GAMP 4
GAMP Document History
NOTE: This CD does not contain an electronic version of GAMP 5.
*Number 1 above
The figures from the GAMP 5 Main Body and Appendix M3 are provided in Microsoft® PowerPoint (suitable for Microsoft®
PowerPoint 2000 or above).
Please note that while every effort has been made to provide the Microsoft® PowerPoint documents in a reusable format,
ISPE does not guarantee that they will appear correctly when opened in Microsoft® PowerPoint or copied to Microsoft® Word
or any other application.
The figures from the GAMP 5 Main Body and Appendix M3 are provided for your convenience. They may be used freely within
your own organization; however, no modifications may be made to the content of these figures and the included copyright
statement should appear on all figures and copies. They remain the property of ISPE, should not be used for commercial
purposes, and are not available for resale.
**Numbers 2 and 3 above
The GAMP 5 example templates, forms, checklists, and questionnaires are provided in Microsoft® Word (suitable for
Microsoft® Word 2000 or above) or Adobe® PDF format.
Please note that while every effort has been made to provide the Microsoft® Word documents in a reusable format, ISPE does
not guarantee that they will appear correctly when opened in Microsoft® Word or another word processing application.
The GAMP 5 example templates, forms, checklists, and questionnaires are provided for your convenience. They may be used
freely within your own organization; however, they remain the property of ISPE, should not be used for commercial purposes,
and are not available for resale.
Disclaimer:
This Guide is meant to assist pharmaceutical manufacturing companies in managing GxP Regulated systems. ISPE cannot ensure and does
not warrant that a system managed in accordance with this Guide will be acceptable to regulatory authorities. Further, this Guide does not
replace 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, including 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 2008. All rights reserved.
All trademarks used are acknowledged.