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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/Editor
Ms. Michelle M. González - Senior Principal Corporate Engineer - Director, Amgen Inc. (Retired) has had extensive experience in leadership activities dealing with facilities and process systems design, facilities engineering, and management of projects. Since relocating to the United States, she has held technical positions of increasing responsibility in mechanical and process engineering with firms such as Shell Oil, Kaiser Engineers, Bechtel Corporation, Fluor Daniel, and Amgen.

Ms. Gonzalez holds an MS in Architecture from the Pontificia Universidad Javeriana in Bogotá, Colombia. She has been a regular lecturer at the Stanford School of Engineering, and holds professional memberships in the American Institute of Chemical Engineers (AIChE), and the American Society of Mechanical Engineers (ASME) Bioprocessing Equipment (BPE) Standard, where she serves as Chair of the BPE's Subcommittee on Surface Finishes, voting member of the Executive and Main Committees, as well as the Certification, and Dimensions & Tolerances Subcommittees.

Ms. González is also  an active member of ISPE where she has been a speaker, a member of the Membership Committee (MSC), the North America Educational Committee (NAEC), and the Body of Knowledge Committee (BOKC); President of the Greater Los Angeles Chapter (2007-2008), and a participating member on the preparation of the ISPE Good Practice Guide for Commissioning and Qualification of Pharmaceutical Water and Steam Systems, the Biopharmaceutical Manufacturing Facilities Baseline® Guide, the Packaging, Labeling and Warehou sing Operations Baseline® Guide, the Laboratories Baseline® Guide, and the revision of the Water & Steam Baseline® Guide. Ms. González has authored various technical papers dealing with materials of construction for the biopharmaceutical industry including "single use" products technology; facilities programming, pilot plants, and biotechnology process systems.
 

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