Dave DiProspero, Co-Team Leader of the ISPE Baseline® Guide: Oral Solid Dosage Forms (Third Edition), offers insight about what brought on the update and what core takeaways you’ll get from the new edition of this Guide.

Key concepts of the OSD Baseline® Guide include:

  • Current and proper application of facility design, engineering, and operational procedures to assist with cGMP compliance
  • Risk management, processes, and tools
  • cGMP and non-GMP technology and its impact upon facility design and costs
  • Product isolation and containment and principles of product, operator, and environmental protection
  • GEP and proper/enhanced documentation

Learn More - ISPE OSD Guide

 

 

 

The ISPE Baseline® Guide: Oral Solid Dosage Forms (Third Edition), is a direct result of the generous and dedicated commitment of numerous individuals, who gave their time, industry experience, and expertise in the Oral Solid Dose form arena:

Douglas C. Becker, Pfizer Inc., USA

Pamela Bruen Docherty, Siemens Industry, Inc., USA

Bernard J. Carroll, PE, Genesis Engineers, Inc., USA

Jack C. Chu, PE/MBA (Co-Lead), RPA Associates/Merck & Co., Inc. retired, USA

Sam Colucci, PE, CEM, LEED AP BD+C, Precis Engineering, USA

James Cox, Merck & Co., Inc., USA

Thomas Cragnolini, VTU Engineering AG, Switzerland

Mike P. DeBellis, Jacobs, USA

Richard Denk, SKAN AG, Switzerland

Dave DiProspero (Co-Lead), CRB Consulting Engineers, USA

Gary Dugdale, BEng (Hons) CEng MIET, AstraZeneca, United Kingdom

Brian J. Egan, IPS, USA

Paul S. Egee, IMA North America, USA

Dr. Andreas Flückiger, F. Hoffmann-La Roche AG, Switzerland

Norman A. Goldschmidt, Genesis Engineers, Inc., USA

David Goswami, IPS, USA

Dennis M. Gross, MS, PhD, Pennsylvania Drug Discovery Institute, USA

Michael Hansen, Johnson & Johnson, USA

Alex Heisterkamp, Pfizer Inc. (retired), USA

Uri Hillel, Teva Pharmaceutical Industries Ltd., Israel

Terry Jacobs, AIA, JacobsWyper Architects, USA

Mark Lashendock, Bristol-Myers Squibb, USA

Tim A. Mallo, PhD, Merck & Co., Inc., USA

Peter Marshall, CEng, MI-ChemE, AstraZeneca, United Kingdom

Jaime E. Martinez, IES Engineers, USA

Robert E. Matje, CPIP (Co-Lead), RemTech, LLC, USA

Shugo Nakayama, Bayer Yakuhin, Ltd., Japan

Paul O’Brien, PM Group, Ireland

Vince O’Brien, Precis Engineering, Inc., USA

John T. Patterson, Merck & Co., Inc. (retired), USA

Aimee Penko, CRB Consulting Engineers, USA

Bruce Rockwell, Duke Energy, USA

Markus Rückert, Pharma Containment Solutions, Germany

George A. Ruiz, BEChe, AstraZeneca, USA

Dr. Leonid Shnayder, PE, Stevens Institute of Technology, USA

Sunil Chand Singhai, Adept Pharma Consultants, India

Stephen J. Sirabian, MBA, Glatt Air Techniques Inc., USA

Ingo Stammnitz, Korsch AG, Germany

Michael W. Vileikis, IPS, USA

Mark S. von Stwolinski, AIA, CRB Consulting Engineers, USA

Paul M. Whitby, Pfizer Inc., USA

Julian Wilkins, PharmaConsult us Inc., USA

Michael Wilson, AIA, CRB Consulting Engineers, USA

James P. Wood, Eli Lilly & Co., USA

 

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