ISPE Guidance Documents

Developed with the assistance of CRB’s thought leaders, ISPE Guidance Documents provide the practical, “real world” information you need to help your company build on current best practices to meet and exceed regulatory standards. CRB has authored 4 of 8 ISPE Baseline® Guides and 3 Good Practice Guides.

Water & Steam Systems Baseline® Guide (2nd Edition) - December 2011

Water & Steam Systems Baseline® Guide (2nd Edition) - December 2011
Ryan Schroeder, Co-Author
Jeff Biskup (Committee)

Biopharmaceutical Process and Manufacturing Guide - October 2013

Biopharmaceutical Process and Manufacturing Guide - October 2013
Mark von Stwolinski, Author

Biopharmaceutical Manufacturing Facilities Baseline® Guide (2nd edition) - December 2013

Biopharmaceutical Manufacturing Facilities Baseline® Guide (2nd edition) - December 2013
Mark von Stwolinski, Chairman
Jeff Biskup, Contributor

Project Management for the Pharmaceutical Industry Good Practice Guide - November 2011

Project Management for the Pharmaceutical Industry Good Practice Guide - November 2011
Trevor Auer, Technical Reviewer

Biopharmaceutical Manufacturing Facilities Baseline® Guide - June 2004

Biopharmaceutical Manufacturing Facilities Baseline® Guide - June 2004
Mark von Stwolinski, Author

Sterile Product Manufacturing Facilities Baseline® Guide - (2nd edition) - September 2011

Sterile Product Manufacturing Facilities Baseline® Guide - (2nd edition) - September 2011
Mark von Stwolinski, Author

Packaging, Labeling and Warehousing Facilities Good Practice Guide - June 2012

Packaging, Labeling and Warehousing Facilities Good Practice Guide - June 2012
Mark von Stwolinski, Author

Operations Management Guidance Document - 2015

Operations Management Guidance Document - 2016
Niranjan Kulkarni, PhD, Co-Author

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