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Baseline® Pharmaceutical Engineering Guides for New and Renovated Facilities
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.
Opportunities available to contribute to the development of Baseline® Guides
Volume 6: Biopharmaceuticals
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Published: June 2004 The Biopharmaceutical Manufacturing Facilities Baseline® Guide explores products and facilities that house biotechnological processes. More specifically, it applies to process design ties to facility design, controlled processing, preventing contamination, and segregation and flow. |
How to buy:
- Order the bound version from the ISPE Online Store
- Also available as a secure PDF* for immediate purchase and download from Techstreet/Thompson Scientific
Related Training Courses:
The Biopharmaceuticals Baseline Guide is used in association with ISPE training course Biopharmaceutical Manufacturing Facilities. Attendees of the training course receive a complimentary copy of this publication.
Volume 6: Biopharmaceuticals Bound / Electronic Set
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The electronic version of the Baseline® Guide features enhanced capabilities including bookmarks and links from the Guide’s Table of Contents for easy access to all sections of the electronic document, as well as pages (thumbnails) for simplicity of navigation. The electronic version is an accurate reproduction of the printed Guide, which is searchable and provided on CD-ROM for portability. The bound / electronic set includes one bound version of the Guide, and one CD containing a PDF document* of the Guide. |
Order the bound / electronic set from the ISPE Online Store
* System requirements and user information for the electronic document.
Volume 5: Commissioning and Qualification
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Published: March 2001 The Commissioning and Qualification Baseline® Guide provides advice and guidance that may be applied to all types of facilities, utilities, and equipment found in the healthcare industry. The Guide has incorporated comments from industry representatives from all areas and disciplines, FDA Field Investigators, and personnel from the FDA's Center for Drug Evaluation and Research (CDER). |
How to Buy:
- Order the bound version from the ISPE Online Store
- Also available as a secure PDF* for immediate purchase and download from Techstreet/Thompson Scientific
Related Training Courses:
The Commissioning and Qualification Baseline Guide is used in association with ISPE training courses Basic Principles of Commissioning and Qualification and Application of Commissioning and Qualification. Attendees of the training course receive a complimentary copy of this publication.
This Guide is currently undergoing a revision. More info...
Volume 5: Commissioning and Qualification Bound / Electronic Set
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The electronic version of the Baseline® Guide features enhanced capabilities including bookmarks and links from the Guide’s Table of Contents for easy access to all sections of the electronic document, as well as pages (thumbnails) for simplicity of navigation. The electronic version is an accurate reproduction of the printed Guide, which is searchable and provided on CD-ROM for portability. The bound / electronic set includes one bound version of the Guide, and one CD containing a PDF document* of the Guide. |
Order the bound / electronic set from the ISPE Online Store
* System requirements and user information for the electronic document.
Volume 4: Water and Steam Systems
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Published: January 2001 The Water and Steam Systems Baseline® Guide is intended for the design, construction, and operation of new water and steam systems. The purpose of this Guide is to focus upon engineering issues and provide cost-effective water and steam systems. The Guide is intended primarily for regulatory compliance for the domestic US market, and follows US standards and references. Issues relating to Europe are discussed in the Guide's appendix. |
How to Buy:
- Order the bound version from the ISPE Online Store
- Also available as a secure PDF* for immediate purchase and download from Techstreet/Thompson Scientific
Related Training Courses:
The Water and Steam Systems Baseline Guide is used in association with ISPE training courses Pharmaceutical Water Generation and Pharmaceutical Water Operation. Attendees of the training course receive a complimentary copy of this publication.
This Guide is currently undergoing a revision. More info...
Volume 4: Water and Steam Systems Bound / Electronic Set
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The electronic version of the Baseline® Guide features enhanced capabilities including bookmarks and links from the Guide’s Table of Contents for easy access to all sections of the electronic document, as well as pages (thumbnails) for simplicity of navigation. The electronic version is an accurate reproduction of the printed Guide, which is searchable and provided on CD-ROM for portability. The bound / electronic set includes one bound version of the Guide, and one CD containing a PDF document* of the Guide. |
Order the bound / electronic set from the ISPE Online Store
* System requirements and user information for the electronic document.
Volume 3: Sterile Manufacturing Facilities
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Published: January 1999 The Sterile Manufacturing Facilities Baseline® Guide addresses the design, construction, commissioning, and qualification of facilities designed for aseptic processing of formulated products. The Guide is designed for use by industry for the design, construction, commissioning, and qualification of new or renovated aseptic/sterile manufacturing facilities. |
How to Buy:
- Order the bound version from the ISPE Online Store
- Also available as a secure PDF* for immediate purchase and download from Techstreet/Thompson Scientific
Related Training Courses:
The Sterile Manufacturing Facilities Baseline Guide is used in association with ISPE training course Sterile Drug Manufacturing Facilities: Applying ISPE Baseline® Guide and FDA Guidance Principles to Design and Operation. Attendees of the training course receive a complimentary copy of this publication.
This Guide is currently undergoing a revision. More info...
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Published: February 1998 Many Oral Solid Dosage (OSD) facilities run multiple products in processing areas designed for quick turnaround without unacceptable risk of product exposure (i.e., dust and cross-contamination). Additionally, potent or toxic active ingredients are becoming increasingly common and present their own design challenges. The Oral Solid Dosage Baseline® Guide assists professionals by establishing consistent and minimum parameters for facility design, which address these concerns and meet GMP requirements. |
How to Buy:
- Order the bound version from the ISPE Online Store
- Also available as a secure PDF* for immediate purchase and download from Techstreet/Thompson Scientific
This Guide is currently undergoing a revision. More info...
Vol. 1, 2nd Edition: Active Pharmaceutical Ingredients
Revision to Bulk Pharmaceutical Chemicals
ISPE Members only: Download Chapter One now! 
Key features of the Guide include:
- Active Pharmaceutical Ingredient characterization
- Critical process steps
- Potential contamination
- Good Engineering Practice
- Levels of protection
- Critical process parameter
- Critical instruments
- Critical unit operation (new)
- Contamination review (new)
- Design qualification (new)
- Intended patient use (new)
- Direct, indirect, and no impact systems (new)
- Critical and non-critical components (new)
- Facility designation (new)
- Process Analytical Technologies (new)
- Process review (new)
- Risk to patient (new)
- Understanding of process (new)
In addition, the revision of this Guide has provided the opportunity to incorporate specific current Good Manufacturing Practices (cGMP) considerations for pharmaceutical manufacturing regions outside the U.S., and has recognized and adopted harmonization work, such as the ICH (International Conference on Harmonisation) Q7 Good Manufacturing Practices for Pharmaceutical Ingredients.
How to buy:
- Order the bound version from the ISPE Online Store
- Also available as a secure PDF* for immediate purchase and download from Techstreet/Thompson Scientific
Page last updated: 08 October 2008
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