This book is intended to provide a background to the quality control
(QC) microbiology function from the perspective of the laboratory, and particularly
from that of the laboratory manager. Sutton focuses on the role of the QC microbiology
laboratory in the pharmaceutical manufacturing environment, and provides "heads-up"
information to the new microbiologist that is going into the pharmaceutical,
medical device or cosmetics industries.
This book will also be useful to the
newly-promoted manager of a microbiology laboratory who might not be comfortable
with all aspects of the QC microbiology lab. Finally, this book will also be
useful to upper management in understanding the microbiology function and assays,
and the frequent trade-off between well-controlled and well-executed tests
on the one hand, and uncertain microbiology data (with the opportunity to conduct
many investigations into unforeseen results) on the other.
The writing style is easy to read, with a minimum of jargon. This book is
not a treatise on the science of microbiology, but a practical (if sometimes
light-hearted) treatment of how a QC microbiology lab functions in the pharmaceutical
and related industries. Pharmaceutical Quality Control
Microbiology: A Guidebook to the Basics will not overpower the newcomer, but provides a wealth of readable
and useful information to all levels of workers.
Book written in June, 2007
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Table of Contents:
Click here to download >>>Detailed Table of Contents
Introduction (Click here to
download >>>Introduction )
1. What is Microbiology and Why Do I
Care?
2. Microbial Growth and Enumeration
3. Laboratory Design
Concerns
4. Microbiology Laboratory Quality Control Practices
5. Microbial
Identification Methods
6. Sterilization
7. Microbiology in the Clean Rooms
and Aseptic Area Aseptic Processing
8. Process Control Tests: Raw Materials,
Media Fills and Environmental Monitoring
9. Finished Product Tests
10.
Investigations
11. Rapid Microbiological Methods in the QC Laboratory
12.
Training
Index
About the
Author
Scott Sutton, PhD earned his B.S. in Genetics from the
University of California at Davis, and his Masters and Ph.D. in Microbiology
from the University of Rochester (Rochester, NY). After an NIH postdoctoral
fellowship at the Medical College of Virginia (Richmond, VA), he joined Bausch
and Lomb (Rochester, NY), and in 1994 he accepted a position at Alcon
Laboratories (Fort Worth, TX) where he became a Director in the R&D
Division. In 2004, he joined Vectech Pharmaceutical Consultants, Inc. as Pharma
Consultant (Microbiology) and is now Senior Director, Microbiology Services for
Vectech. Dr. Sutton is an active author and speaker for the industry. In
addition, he is active in a volunteer capacity, being involved with the USP
Analytical Microbiology Committee of Experts since 1993.