Author: Rosamund M. Baird
Publisher: CRC Press
ISBN: 0203305191
Category : Medical
Languages : en
Pages : 274
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Book Description
Microbiologists working in both the pharmaceutical and medical device industries, face considerable challenges in keeping abreast of the myriad microbiological references available to them, and the continuously evolving regulatory requirements. The Handbook of Microbiological Quality Control provides a unique distillation of such material, by provi
Author: David Roesti
Publisher: John Wiley & Sons
ISBN: 1119356075
Category : Technology & Engineering
Languages : en
Pages : 594
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Book Description
Relying on practical examples from the authors’ experience, this book provides a thorough and modern approach to controlling and monitoring microbial contaminations during the manufacturing of non-sterile pharmaceuticals. Offers a comprehensive guidance for non-sterile pharmaceuticals microbiological QA/QC Presents the latest developments in both regulatory expectations and technical advancements Provides guidance on statistical tools for risk assessment and trending of microbiological data Describes strategy and practical examples from the authors’ experience in globalized pharmaceutical companies and expert networks Offers a comprehensive guidance for non-sterile pharmaceuticals microbiological QA/QC Presents the latest developments in both regulatory expectations and technical advancements Provides guidance on statistical tools for risk assessment and trending of microbiological data Describes strategy and practical examples from the authors’ experience in globalized pharmaceutical companies and expert networks
Author: Jon Michael Miller
Publisher:
ISBN:
Category : Microbiological laboratories
Languages : en
Pages : 116
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Book Description
Author: Tim Sandle
Publisher: Woodhead Publishing
ISBN: 0081000448
Category : Science
Languages : en
Pages : 316
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Book Description
Pharmaceutical Microbiology: Essentials for Quality Assurance and Quality Control presents that latest information on protecting pharmaceutical and healthcare products from spoilage by microorganisms, and protecting patients and consumers. With both sterile and non-sterile products, the effects can range from discoloration to the potential for fatality. The book provides an overview of the function of the pharmaceutical microbiologist and what they need to know, from regulatory filing and GMP, to laboratory design and management, and compendia tests and risk assessment tools and techniques. These key aspects are discussed through a series of dedicated chapters, with topics covering auditing, validation, data analysis, bioburden, toxins, microbial identification, culture media, and contamination control. Contains the applications of pharmaceutical microbiology in sterile and non-sterile products Presents the practical aspects of pharmaceutical microbiology testing Provides contamination control risks and remediation strategies, along with rapid microbiological methods Includes bioburden, endotoxin, and specific microbial risks Highlights relevant case studies and risk assessment scenarios
Author: Scott Sutton
Publisher:
ISBN: 9781933722085
Category : Pharmaceutical industry
Languages : en
Pages : 0
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Book Description
Author:
Publisher: John Wiley & Sons
ISBN: 1555818811
Category : Medical
Languages : en
Pages : 2954
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Book Description
In response to the ever-changing needs and responsibilities of the clinical microbiology field, Clinical Microbiology Procedures Handbook, Fourth Edition has been extensively reviewed and updated to present the most prominent procedures in use today. The Clinical Microbiology Procedures Handbook provides step-by-step protocols and descriptions that allow clinical microbiologists and laboratory staff personnel to confidently and accurately perform all analyses, including appropriate quality control recommendations, from the receipt of the specimen through processing, testing, interpretation, presentation of the final report, and subsequent consultation.
Author: M.R.W. Brown
Publisher: CRC Press
ISBN: 1351083007
Category : Science
Languages : en
Pages : 317
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Book Description
Microbiological Quality Assurance: A Guide Towards Relevance and Reproducibility of Inocula sheds light on the difficulties of obtaining results in the test tube that will be reproducible and relevant for a wide variety of tests. This book explores the current state of research in this area and troubleshoots the problems that may be encountered in setting up appropriate cultures. The text divides naturally into three sections-growth conditions, post-growth conditions, and applications. This book serves as a valuable resource for clinical microbiologists, pharmacologists, and anyone doing in vitro experiments.
Author: N.F. Lightfoot
Publisher: Elsevier
ISBN: 0080536514
Category : Technology & Engineering
Languages : en
Pages : 285
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Book Description
With the help of leading Quality Assurance (QA) and Quality Control (QC) microbiology specialists in Europe, a complete set of guidelines on how to start and implement a quality system in a microbiological laboratory has been prepared, supported by the European Commission through the Measurement and Testing Programme. The working group included food and water microbiologists from various testing laboratories, universities and industry, as well as statisticians and QA and QC specialists in chemistry. This book contains the outcome of their work. It has been written with the express objective of using simple but accurate wording so as to be accessible to all microbiology laboratory staff. To facilitate reading, the more specialized items, in particular some statistical treatments, have been added as an annex to the book. All QA and QC tools mentioned within these guidelines have been developed and applied by the authors in their own laboratories. All aspects dealing with reference materials and interlaboratory studies have been taken in a large part from the projects conducted within the BCR and Measurement and Testing Programmes of the European Commission. With so many different quality control procedures, their introduction in a laboratory would appear to be a formidable task. The authors recognize that each laboratory manager will choose the most appropriate procedures, depending on the type and size of the laboratory in question. Accreditation bodies will not expect the introduction of all measures, only those that are appropriate for a particular laboratory. Features of this book: • Gives all quality assurance and control measures to be taken, from sampling to expression of results • Provides practical aspects of quality control to be applied both for the analyst and top management • Describes the use of reference materials for statistical control of methods and use of certified reference materials (including statistical tools).
Author: Antonio Bevilacqua
Publisher: Woodhead Publishing
ISBN: 0081005032
Category : Technology & Engineering
Languages : en
Pages : 348
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Book Description
The Microbiological Quality of Food: Foodborne Spoilers specifically addresses the role of spoilers in food technology and how they affect the quality of food. Food spoilers represent a great challenge in food quality, determining the shelf-life of many products as they impact consumer acceptability of taste, texture, aroma, and other perceptions. Divided into four sections, the first section defines microbial spoilage of food, with special emphasis on methods for the evaluation of spoiling phenomena and the status of their regulatory framework, examining both existing regulations and possible gaps. The second section examines spoiling microorganisms, covering a range of common spoilage microorganisms, including pseudomonas, yeasts, and molds and spore formers, as well as less-common spoilers, including lactic acid bacteria and specific spoilage organisms in fish. The third section highlights spoiling phenomena within certain food types. Chapters cover dairy, fish, meat, and vegetables, and other products. The final section investigates emerging topics which point to future trends in the research of food spoilers. There is insight into microorganisms resistant to preservation, the role of biofilms in food quality, and the link between food safety and food spoilage, with a special emphasis on certain spoiling microorganisms which could be opportunistic pathogens. Written by an international team of leading authors, this book provides state-of-the-art coverage of this topic, which is essential to the shelf-life and quality of food. Provides in-depth coverage of the different spoilers which cause the deterioration of foods, including less common spoilers not covered in other publications Includes dedicated chapters covering the spoilage of specific products, making this book ideal for those working in the food industry Presents a framework for future research in the area of foodborne spoilers
Author: United States. Food Safety and Inspection Service. Microbiology Division
Publisher:
ISBN:
Category : Agricultural microbiology
Languages : en
Pages : 556
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Book Description
