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
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
One of the most significant changes to the pharmaceutical industry in the last decade has been the increased speed in developing new therapies. A striking example of this is the rapid rollout of the COVID-19 vaccines. What usually took 10-15 years was researched, developed, and put into production...
Biocon Biologics is one of the 2021 Facility of the Year Awards Winner for the 2021 Facility of the Year Honorable Mention Award for their Biocon Biologics Manufacturing (B3) project in Bangalore, India.
ICH Q10 outlines three objectives: achieve product realization, establish and maintain a state of control, and facilitate continual improvement. Embracing these objectives can be best achieved using the dual enablers, Knowledge Management (KM) and Quality Risk Management (QRM). The pharmaceutical...