ISPE Releases Active Pharmaceutical Ingredients (Bulk) Guide

July 2, 2007

ISPE, a global not-for-profit Society of pharmaceutical manufacturing professionals representing more than 23,000 Members, has released ISPE Baseline® Guide Volume 1, Active Pharmaceutical Ingredients, Second Edition.

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.

This is the second edition of ISPE's Baseline® Guide Volume 1, Active Pharmaceutical Ingredients, originally called Bulk Pharmaceutical Chemicals. It was the first of the Baseline® Guide series to be produced (in 1996) and is the first to be revised.

"This revision was prompted by a number of developments and initiatives within the industry, along with comments from users of the original Guide," according to Patrick Wong, of Bristol-Myers Squibb, and Leader of the Document Development Task Team responsible for the Guide.

This revised Guide builds on the original principles, but also incorporates and builds on new regulations and guidance, such as:

ICH Q7
ICH Q9
GAMP 4
Later ISPE Baseline® Pharmaceutical Engineering Guide Series
21 CFR Part 11
"Guidance for Industry, Sterile Drug Products Produced by Aseptic Processing – Current Good Manufacturing Practice"
FDA Draft Guidance for Industry PAT – A Framework for Innovative Pharmaceutical Manufacturing and Quality Assurance

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 US, and has recognized and adopted harmonization work, such as the ICH (International Conference on Harmonisation) Q7 Good Manufacturing Practices for Pharmaceutical Ingredients.

The scope has been expanded and key features of the Guide now include:

Active Pharmaceutical Ingredient Characterization
Critical Process Step(s)
Critical Unit Operation (new)
Critical Process Parameter
Critical Instruments
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)
Potential Contamination
Good Engineering Practice
Levels of Protection
Process Analytical Technologies (new)
Process Review (new)
Risk to Patient (new)
Understanding of Process (new)

Guide may be purchased for $200 by Members and $400 for non-members by visiting www.ispe.org/cs/root/publications/baseline_guides or by calling Customer Service at +1-813-960-2105.

About ISPE
ISPE, the International Society for Pharmaceutical Engineering, is the Society of choice for more than 23,000 pharmaceutical manufacturing professionals in 90 countries around the globe. ISPE aims to be the catalyst for "Engineering Pharmaceutical Innovation" by providing Members with opportunities to develop technical knowledge, exchange practical experience, and collaborate with global regulatory agencies and industry leaders. Founded in 1980, ISPE has worldwide headquarters in Tampa, Florida, USA; its European office in Brussels, Belgium; and its Asia Pacific office in Singapore. Visit www.ispe.org for additional Society news and information.

Source: ISPE

ISPE