GMP Spezial

Microbiologists and management alike are working together to remove the perceived barriers to implementing RMM in their own companies. Other industry sectors (e.g., clinical, cosmetic and personal care, food and beverage, municipal water authorities) have employed RMM technologies to monitor microbiological control in their manufacturing operations for many years, and the pharmaceutical industry should learn from their experiences and successes.

The three volume Encyclopedia of Rapid Microbiological Methods focuses on regulatory and compendial initiatives currently in place that will help pharmaceutical microbiologists begin the journey of implementing RMM in their facilities and describes the many rapid methods currently available.

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Key Topics include:

Volume I
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Overview of microbiological methods and opportunities for industry
Regulatory and Compendial Perspectives
Validation Strategies

Volume II
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Growth-Based Technologies
Viability-Based Technologies

Volume III
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Artifact-Based Technologies
Nucleic Acid-Based Technologies
Rapid detection of Mycoplasma
Microarrays, Biochips and Biosensorts

Michael J. Miller, PhD is a Senior Research Fellow for Eli Lilly and Company, and is responsible for technical leadership in microbiology and sterility assurance within Manufacturing, Quality, Engineering, and Product Development. He He is also accountable for driving Lilly's corporate initiatives for Process Analytical Technology (PAT), barrier isolation technology and rapid microbiological methods. Dr. Miller has authored over 60 technical publications and presentations in the areas of rapid microbiological methods, PAT, ophthalmics, disinfection and sterilization, and has served as Chairperson for numerous rapid microbiological methods technical conferences in the United States and Europe. He was the Program Chairperson for the 2001 PDA Spring Meeting on Modern Pharmaceutical Microbiology, the Program Chairperson for the 2005 PDA Annual Meeting, and is currently serving on PDA`s strategic planning, program, and publication committees and advisory boards. He also serves as the Chairperson for USP Technical Committee 18, Working Group 6, which is responsible for developing a general chapter on rapid microbiological methods. Dr. Miller has a PhD in Microbiology and Biochemistry from Georgia State University (GSU), and has served as an adjunct professor at GSU and the University of Waterloo School of Optometry.

PDA/DHI Publication

Volume I : 2005. 404 Pages. ISBN: 1-930114-85-0.
Volume II : 2006. 468 Pages. ISBN: 1-930114-86-9.
Volume III : 2006. 480 Pages. ISBN: 1-930114-87-7.