Using the ISPE Electronic Technical Documents

The ISPE electronic document is an electronic document is developed to run directly from your CD-ROM drive.

System Information
Recommended minimum system configuration:

• Windows® 98 (Second Edition), ME, 2000, or XP (Professional or Home Edition)
• 500MHz Intel® Pentium III® (or comparable) processor
• 64 MB of RAM (128 MB Ram for windows 2000/256MB RAM for Windows XP)
• 16x CD ROM/DVD
• Windows® compatible mouse

Important Notes:

1. The ISPE electronic document will not run if copied to another drive.
2. The ISPE electronic document will not run if an Adobe® Reader® application is already running. To view other documents within Adobe® Reader® at the same time, close all instances of Adobe® Reader®. Open the ISPE electronic document electronic document first and then open other required documents.
3. When the CD is run for the first time, you may be requested to accept an Adobe® Reader® License Agreement. If this License Agreement is not accepted, you will be unable to read the ISPE electronic document.

The ISPE electronic document is designed to launch automatically when the CD-ROM is inserted into your CD-ROM drive.

If the electronic document does not launch automatically, open the ISPE electronic document by launching the Folaunch.exe from the CD-ROM. This can be achieved either by using the Run option on your Start menu or by using Windows Explorer.

Under Windows® NT based systems, a user with power user or higher privileges may need to run the CD-ROM using the autorun (autorun.exe) feature, before subsequent users can run the CD-ROM without having to navigate to the Folaunch.exe file.

The cover page will then appear within Adobe® Reader®.

Viewing Content
The content of the ISPE electronic document is viewable using the normal functionality of Adobe® Reader®.

Bookmarks and links from the Table of Contents have been included to provide easy access to all sections of the electronic document.

Pages (thumbnails) also are available for ease of navigation.

Note: Blank pages are included as they appear in the paper copy of the document.

Printing and Copying
Since the document is designed to be read electronically and a printed book was included in the purchase price, print functionality is not included.

No copying functionality is provided in accordance with the terms of the copyright.

Adobe® Reader®
The Acrobat6/Install folder contains the AdbeRdr60_DLM_enu_full.exe file, which may be used to install an Adobe® Reader® application. Running this file will cause the Adobe® Reader® installation to commence. This is NOT required for viewing the ISPE electronic document, which runs directly from the CD-ROM.

Adobe® Reader® may provide several options on first use. These may include the following:

Netscape and Internet Explorer
It is suggested that the user uncheck the “Always perform this check when starting Acrobat®” checkbox on this window and answer “No” to enabling view PDF documents in Netscape or Internet Explorer.

Adobe Picture Tasks
It is suggested that the “Don’t Show Again” checkbox is checked. The user does not have permission to export or edit pictures from in the file.

Updating Acrobat®
The user may prefer to set the “Check for Updates” option to manual. Instructions on changing such preferences may be found in the Adobe® Help file (Index: updating, Acrobat®).

This information is provided only for the convenience of the user – the ISPE electronic document does not require any changes to settings or preferences other than those described earlier in this booklet.

Note: It is recommended that plug-ins, Adobe® or third party, and advanced features of Adobe® Reader® are not used from the ISPE electronic document CD-ROM version of Adobe® Reader®.

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.

Credits
This electronic document was designed and produced by ISPE. It contains the content of the paper version of the ISPE electronic document.

All trademarks used are acknowledged and are the property of their respective owners.

Additional Materials
Any additional materials that are included on the CD-ROM are provided for your convenience. They remain the property of ISPE, should not be used for commercial purposes, and are not available for resale.

Figures 12-1, 12-2, and 12-3 from the Biopharmaceutical Manufacturing Facilities Baseline® Guide may be found in a separate “Additional Materials” folder on the Biopharmaceutical Manufacturing Facilities Baseline® Guide CD-ROM. These are provided in Adobe® PDF format and are in color for ease of viewing. They remain the property of ISPE and are not available for resale.

The attachments to GAMP 4 may be found in a separate “Additional Materials” folder on the GAMP 4 CD-ROM. These are provided in Microsoft® Word (suitable for Microsoft® Word 2000 or above) or Adobe® PDF format.

The GAMP 4 attachments, example templates, forms, and procedures 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.