Handbook of Microbiological Quality Control in Pharmaceuticals and Medical Devices PDF Download
Are you looking for read ebook online? Search for your book and save it on your Kindle device, PC, phones or tablets. Download Handbook of Microbiological Quality Control in Pharmaceuticals and Medical Devices PDF full book. Access full book title Handbook of Microbiological Quality Control in Pharmaceuticals and Medical Devices by Rosamund M. Baird. Download full books in PDF and EPUB format.
Author: Rosamund M. Baird
Publisher: CRC Press
ISBN: 0203305191
Category : Medical
Languages : en
Pages : 274
Get Book Here
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: Rosamund M. Baird
Publisher: CRC Press
ISBN: 0203305191
Category : Medical
Languages : en
Pages : 274
Get Book Here
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: J. J. S. Snell
Publisher:
ISBN:
Category : Business & Economics
Languages : en
Pages : 180
Get Book Here
Book Description
This manual sets out the principles of quality control and provides clear, detailed information on the practical ways in which quality control can be achieved in the microbiology laboratory.
Author: David Roesti
Publisher: John Wiley & Sons
ISBN: 1119356075
Category : Technology & Engineering
Languages : en
Pages : 594
Get Book Here
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: Tim Sandle
Publisher: Woodhead Publishing
ISBN: 0081000448
Category : Science
Languages : en
Pages : 318
Get Book Here
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: N.F. Lightfoot
Publisher: Elsevier
ISBN: 0080536514
Category : Technology & Engineering
Languages : en
Pages : 285
Get Book Here
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: M.R.W. Brown
Publisher: CRC Press
ISBN: 1351083007
Category : Science
Languages : en
Pages : 317
Get Book Here
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: Eileen Ruiz-Perez, PhD
Publisher: Independently Published
ISBN:
Category :
Languages : en
Pages : 0
Get Book Here
Book Description
This book is a concise guide to know and understand the exciting field of microbiology and its application in the industry. The book is for those who do not know microbiology and want to review the fundamental concepts applied to the life sciences industry. It is also for those working in the pharmaceutical and medical device industries and interact in one way or another with Microbiology. The content is helpful for engineers, managers, and quality personnel who must make decisions based on microbiological results. Also, operations and manufacturing personnel interact with microbiology personnel while they perform environmental monitoring or testing. Manufacturing representatives send routine samples to the laboratory for the required quality control tests. The topics include: What are Microorganisms? Characterization Culture media Quality Control in Microbiology Microbiology Role in the Industry Microbiological testing Cleanroom and Controlled Environment Areas Environmental Monitoring of Cleanrooms Reporting and Trending Results Spores as Biological Indicators
Author:
Publisher: John Wiley & Sons
ISBN: 1555818811
Category : Medical
Languages : en
Pages : 2954
Get Book Here
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: Scott Sutton
Publisher:
ISBN: 9781933722085
Category : Pharmaceutical industry
Languages : en
Pages : 0
Get Book Here
Book Description
Author: Basil Jarvis
Publisher: Academic Press
ISBN: 0128039744
Category : Technology & Engineering
Languages : en
Pages : 354
Get Book Here
Book Description
Statistical Aspects of the Microbiological Examination of Foods, Third Edition, updates some important statistical procedures following intensive collaborative work by many experts in microbiology and statistics, and corrects typographic and other errors present in the previous edition. Following a brief introduction to the subject, basic statistical concepts and procedures are described including both theoretical and actual frequency distributions that are associated with the occurrence of microorganisms in foods. This leads into a discussion of the methods for examination of foods and the sources of statistical and practical errors associated with the methods. Such errors are important in understanding the principles of measurement uncertainty as applied to microbiological data and the approaches to determination of uncertainty. The ways in which the concept of statistical process control developed many years ago to improve commercial manufacturing processes can be applied to microbiological examination in the laboratory. This is important in ensuring that laboratory results reflect, as precisely as possible, the microbiological status of manufactured products through the concept and practice of laboratory accreditation and proficiency testing. The use of properly validated standard methods of testing and the verification of 'in house' methods against internationally validated methods is of increasing importance in ensuring that laboratory results are meaningful in relation to development of and compliance with established microbiological criteria for foods. The final chapter of the book reviews the uses of such criteria in relation to the development of and compliance with food safety objectives. Throughout the book the theoretical concepts are illustrated in worked examples using real data obtained in the examination of foods and in research studies concerned with food safety. - Includes additional figures and tables together with many worked examples to illustrate the use of specific procedures in the analysis of data obtained in the microbiological examination of foods - Offers completely updated chapters and six new chapters - Brings the reader up to date and allows easy access to individual topics in one place - Corrects typographic and other errors present in the previous edition
