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The ISPE Glossary of Pharmaceutical and Biotechnology Terminology is the result of many years of gathering material from sources such as scientific journals, industrial magazines, professional organizations, the world wide web, industry seminars, company guides, vendor and manufacturer information, national and international codes, and diverse individuals. This compilation of abbreviations, acronyms, and terminology is a reference for engineers, designers, technicians, owners, contractors, and others in the pharmaceutical and biopharmaceutical industries. It includes terms used in water treatment, welding, metallurgy, medicine, biology, chemistry, computer technology, manufacturing processes, HVAC, etc.

The Glossary includes terms from the following sources:

• American Society of Mechanical Engineers (ASME), Bioprocessing Equipment (BPE), 2002 Revision
• Committees on Human research
• FDA Glossary of Computerized System and Software Development Technology
• GAMP 4, Good Automated Manufacturing Practice Guide for Validation of Automated Systems
• GAMP Good Practice Guides
• ICH Harmonised Tripartite Guide "Good Manufacturing Practice Guide for Active Pharmaceutical Ingredients" Q7a
• ISO/TC209 Working Groups at 2001-03-31 - Committee Draft ISO/CD 14644-6 "Cleanrooms and associated controlled environments" - Part 6: Terms and Definitions
• ISPE Baseline Guides for New and Renovated Facilities
• ISPE Guides and Good Practice Guides
• GAMP5 and GAMP Good Practice Guides
• Rules and Guidance for Pharmaceutical Manufacturers and Distributors. Medicines Control Agency (MCA)
  

About the Author

Michelle M. Gonzalez, P.E. retired in 2007 as an Engineering Director, with Amgen Inc. in Thousand Oaks, California.  Ms. Gonzalez has had an extensive career in industry leadership activities dealing with facilities engineering, process systems design, and management of construction projects with firms such as Shell Oil, Kaiser Engineers, Bechtel Corporation, Fluor Daniel, and Amgen; she is now involved with her own research projects and biopharmaceutical industry technical consulting. Ms. Gonzalez holds an MS in Architecture from the Pontificia Universidad Javeriana in Bogotá, Colombia.

She is a member of AIChE, and ASME’s Bioprocessing Equipment (BPE) Standard, where she has served as Chair of the Surface Finish Subcommittee, and voting member of the BPE Main Committee and Certification Subcommittee.  For the past five years she has also been a member of the Advisory Board for INTERPHEX, the leading annual biopharmaceutical trade show.

As an active member of The International Society for Pharmaceutical Engineering (ISPE), she does presently serve as a member of the Knowledge Assets Committee; Pharmaceutical Engineering Committee and Reviewers; Annual Meeting Planning Event Committee; and the Steering Committee of the Critical Utilities Community of Practice (CU COP).

Ms. Gonzalez has also been a co-author of ISPE’s “Biopharmaceutical Manufacturing and Process Development Baseline® Guide” (2004); “Good Practice Guide for Commissioning and Qualification of Pharmaceutical Water and Steam Systems” (2007); Second Edition of the “Water & Steam Baseline® Guide” (2011); “Good Practice Guide for Process Gases” (2011); “Good Practice Guide for Ozone Sanitization of Pharmaceutical Water Systems” (2012); and "Good Practice Guide for Quality Laboratory Facilities” (2012).

She has also been a regular technical speaker in the US and Europe and contributing writer to ISPE’s Pharmaceutical Engineering and other technical journals, President of the ISPE’s Greater Los Angeles Chapter (2007-2008), and the author and editor of ISPE's Glossary of Applied Terminology for the Pharmaceutical Industry.

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