This relatively small handbook is an in-depth treatise covering almost all the aspects of microbiological quality control in the industrial/pharmaceutical setting. It addresses regulatory issues, microbiological methods and procedures, and approaches to good quality assurance practices. This book is designed to provide guidance to the microbiologist involved in the development, manufacture, production, or quality control of pharmaceuticals, cosmetics, or medical or diagnostic devices. It is directed at approaches to control, detect, and correct microbial contamination problems. It should be noted that this handbook is based primarily on regulations and manufacturing laws and practices in Great Britain, thus its application may be viewed as limited; however, many of the practices are indeed universal and can pertain or apply to any industrial setting. The reader who will benefit most from this text is the microbiologist at the technologist, supervisory, or management level working in the industrial setting who is responsible for procedure or test design, development, and evaluation; testing of reagents, drugs, products, or diagnostic or medical devices; general microbiological quality control and assurance activities; or auditing and inspecting these practices and processes in the industrial laboratory. The editors have drawn upon the expertise and experiences of a variety of individuals from academia, government, and industry to serve as authors for the various chapters. This book is most useful as a reference or guide and should be readily available for use at the bench or desk. Its contents are laid out in a very practical manner, starting with a description of laws and regulationsthat apply to safe microbiological laboratory practices dealing with products or services that directly affect the consumer. The next chapters discuss media, procedures for sampling and enumeration, and identification of bacteria, rapid and unique methods for their detection, and, lastly, specialty applications such as sterility testing, endotoxin and antimicrobial assays, and auditing and inspections. The last chapter of the book provides some excellent examples through case studies and methods for statistical analysis. Some unique features of the book include the numerical annotations of the chapters and subsections that provide for ready and easy reference, descriptions of laboratory procedures and laboratory design, and discussions on principles as well as practical aspects of microbiological quality assurance. In the original concept of this handbook, the authors sought to provide a companion text to Baird's Guide to Microbiological Control: Pharmaceuticals and Medical Devices (Taylor and Francis, 2000). The authors state that it is extensively cross-referenced with that guide. Nevertheless, this handbook can stand alone because it provides detailed information on methods and techniques used in microbiology quality control practices. In the U.S., the closest publications for comparison are Trautman's The FDA and Worldwide Quality System Requirements Guidebook for Medical Devices(ASQC Press, 1996) and a variety of guidelines published by the U.S. Food and Drug Administration. These and many other excellent U.S. and Canadian references and methodology are not cited. Because of these omissions and the fact that the first chapter refers almost exclusively to British regulations and law, readers may assume that the primary audience is British industry and associated microbiologists. To the contrary, the primary value of this handbook is that it contains a wide variety of procedures and methods supported by theory, principles, and the appropriate laws and regulations.
Reviewer: R.J. Zabransky, PhD (Case Western Reserve University)
Description: This relatively small handbook is an in-depth treatise covering almost all the aspects of microbiological quality control in the industrial/pharmaceutical setting. It addresses regulatory issues, microbiological methods and procedures, and approaches to good quality assurance practices.
Purpose: This book is designed to provide guidance to the microbiologist involved in the development, manufacture, production, or quality control of pharmaceuticals, cosmetics, or medical or diagnostic devices. It is directed at approaches to control, detect, and correct microbial contamination problems. It should be noted that this handbook is based primarily on regulations and manufacturing laws and practices in Great Britain, thus its application may be viewed as limited; however, many of the practices are indeed universal and can pertain or apply to any industrial setting.
Audience: The reader who will benefit most from this text is the microbiologist at the technologist, supervisory, or management level working in the industrial setting who is responsible for procedure or test design, development, and evaluation; testing of reagents, drugs, products, or diagnostic or medical devices; general microbiological quality control and assurance activities; or auditing and inspecting these practices and processes in the industrial laboratory. The editors have drawn upon the expertise and experiences of a variety of individuals from academia, government, and industry to serve as authors for the various chapters.
Features: This book is most useful as a reference or guide and should be readily available for use at the bench or desk. Its contents are laid out in a very practical manner, starting with a description of laws and regulations that apply to safe microbiological laboratory practices dealing with products or services that directly affect the consumer. The next chapters discuss media, procedures for sampling and enumeration, and identification of bacteria, rapid and unique methods for their detection, and, lastly, specialty applications such as sterility testing, endotoxin and antimicrobial assays, and auditing and inspections. The last chapter of the book provides some excellent examples through case studies and methods for statistical analysis. Some unique features of the book include the numerical annotations of the chapters and subsections that provide for ready and easy reference, descriptions of laboratory procedures and laboratory design, and discussions on principles as well as practical aspects of microbiological quality assurance.
Assessment: In the original concept of this handbook, the authors sought to provide a companion text to Baird's Guide to Microbiological Control: Pharmaceuticals and Medical Devices (Taylor and Francis, 2000). The authors state that it is extensively cross-referenced with that guide. Nevertheless, this handbook can stand alone because it provides detailed information on methods and techniques used in microbiology quality control practices. In the U.S., the closest publications for comparison are Trautman's The FDA and Worldwide Quality System Requirements Guidebook for Medical Devices(ASQC Press, 1996) and a variety of guidelines published by the U.S. Food and Drug Administration. These and many other excellent U.S. and Canadian references and methodology are not cited. Because of these omissions and the fact that the first chapter refers almost exclusively to British regulations and law, readers may assume that the primary audience is British industry and associated microbiologists. To the contrary, the primary value of this handbook is that it contains a wide variety of procedures and methods supported by theory, principles, and the appropriate laws and regulations.
