ISPE Technical Guides Overview

ISPE Baseline® Guides

Created in partnership with the US Food and Drug Administration (FDA), ISPE's Baseline® Guides offer practical answers to the complex, dynamic challenges facing facility designers today. In addition to providing an understanding of products and processes, they also offer an outline of architectural and utility systems needed to meet government requirements. Additionally, they address GMP and non-GMP regulations and detail facility commissioning and qualification.

• Download a complete Baseline® Guide Brochure (PDF)

Published Baseline® Guides:

• Volume 6: Biopharmaceuticals
• Volume 5: Commissioning and Qualification
• Volume 4: Water and Steam Systems
• Volume 3: Sterile Manufacturing Facilities
• Volume 2: Oral Solid Dosage
• Volume 1, 2nd Ed.: Active Pharmaceutical Ingredients (Revision to Bulk Pharmaceutical Chemicals Guide) - Receive white paper with purchase

Baseline® Guides Under Development:

• See all Baseline Guides currently under development

More Information

• A Guide to the Guides
• Opportunities available to contribute to the development of Baseline® Guides

GAMP® and GAMP® Good Practice Guides

Reflecting current regulatory expectations and good practices, the GAMP® 5 Guide and the GAMP series of Good Practice Guides help to narrow interpretation of regulatory standards for improved compliance and quality, efficiency, and cost reductions.

• GAMP® 5: A Risk-Based Approach to Compliant GxP Computerized Systems

GAMP® Good Practice Guides, published:

• Calibration Management
• Electronic Data Archiving
• Global Information Systems
• IT Infrastructure Control and Compliance
• Legacy Systems
• Risk-Based Approach to Electronic Records and Signatures
• Testing of GxP Systems
• Validation of Laboratory Computerized Systems
• Validation of Process Controls Systems

GAMP® Good Practice Guides Under Development:

• See all GAMP® Good Practice Guides currently under development

ISPE Good Practice Guides

ISPE Good Practice Guides (GPGs) provide information or advise on a particular topic area and explain underlying technical principles and suggest solutions in an area where no single answer is correct and where several outcomes may be possible. GPGs address technical areas related to facilities and pharmaceutical manufacturing, and may highlight topics that propose how to meet the intent of a specific aspect of a GMP.

• Maintenance
• Good Engineering Practice
• Development of Investigational Therapeutic Biological Products
• Commissioning and Qualification of Pharmaceutical Water and Steam Systems
• Assessing the Particulate Containment Performance of Pharmaceutical Equipment
• Technology Transfer

ISPE Good Practice Guides Under Development:

• See all ISPE Good Practice Guides currently under development