8/10/2019 Gamp 5 CD Contents

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Contents of GAMP 5 CD

Copyright in the whole and every part of this material is owned by ISPE. No reproduction for commercialpurposes, 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 theirorganization only. The material is indicative only and intended to be neither exhaustive nor prescriptive.

The CD consists of:

1. Figures from the GAMP 5 Main Body and Appendix M3*2. Example Forms and Templates**3. Example Checklists and Questionnaires**4. GAMP 4 to GAMP 5 Summary5. Historical Acknowledgements including GAMP 46. GAMP Document History

NOTE: This CD does notcontain 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 MicrosoftPowerPoint 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 Wordor any other application.

The figures from the GAMP 5 Main Body and Appendix M3 are provided for your convenience. They may be used freely withinyour own organization; however, no modifications may be made to the content of these figures and the included copyrightstatement should appear on all figures and copies. They remain the property of ISPE, should not be used for commercialpurposes, 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 forMicrosoft 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 doesnot 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 usedfreely 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 doesnot warrant that a system managed in accordance with this Guide will be acceptable to regulatory authorities. Further, this Guide does notreplace the need for hiring professional engineers or technicians.

Limitation of LiabilityIn no event shall ISPE or any of its affiliates, or the officers, directors, employees, members, or agents of each of them, be liable for anydamages of any kind, including without limitation any special, incidental, indirect, or consequential damages, whether or not advised of thepossibility 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.