Download or read book Pharmaceutical Microbiological Quality Assurance and Control written by David Roesti and published by John Wiley & Sons. This book was released on 2020-01-02 with total page 594 pages. Available in PDF, EPUB and Kindle. Book excerpt: 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
Download or read book Quality Control QC Microbiology written by Eileen Ruiz-Perez, PhD and published by Independently Published. This book was released on 2022-11-07 with total page 0 pages. Available in PDF, EPUB and Kindle. Book excerpt: 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
Download or read book Microbiological Analysis of Food and Water written by N.F. Lightfoot and published by Elsevier. This book was released on 1998-04-22 with total page 285 pages. Available in PDF, EPUB and Kindle. Book excerpt: 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).
Download or read book Pharmaceutical Microbiology written by Tim Sandle and published by Woodhead Publishing. This book was released on 2015-10-09 with total page 318 pages. Available in PDF, EPUB and Kindle. Book excerpt: 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
Download or read book Pharmaceutical Quality Control Microbiology written by Scott Sutton and published by . This book was released on 2007 with total page 0 pages. Available in PDF, EPUB and Kindle. Book excerpt:
Download or read book Quality Control in Microbiology written by Jon Michael Miller and published by . This book was released on 1987 with total page 116 pages. Available in PDF, EPUB and Kindle. Book excerpt:
Download or read book Microbiological analysis of food and water guidelines for quality assurance written by Nigel F. Lightfoot and published by . This book was released on 1999 with total page 266 pages. Available in PDF, EPUB and Kindle. Book excerpt:
Download or read book Handbook of Microbiological Quality Control in Pharmaceuticals and Medical Devices written by Rosamund M. Baird and published by CRC Press. This book was released on 2000-08-17 with total page 274 pages. Available in PDF, EPUB and Kindle. Book excerpt: 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
Download or read book Quality Control written by J. J. S. Snell and published by . This book was released on 1992-07-23 with total page 180 pages. Available in PDF, EPUB and Kindle. Book excerpt: 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.
Download or read book Microbiological Quality Assurance written by M.R.W. Brown and published by CRC Press. This book was released on 2018-01-18 with total page 317 pages. Available in PDF, EPUB and Kindle. Book excerpt: 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.
Download or read book Microbial Quality Assurance in Pharmaceuticals Cosmetics and Toiletries written by R. Baird and published by CRC Press. This book was released on 1996-05-01 with total page 284 pages. Available in PDF, EPUB and Kindle. Book excerpt: The importance of quality assurance in the production, storage and use of manufactured preparations is widely recognized. This book encapsulates the issues involved in the manufacture of non-steriles, such as creams, ointments, herbal remedies, shampoos, soaps and toiletry products (as opposed to sterile drugs and injectible products). Knowledge of the microbial limits is expanded, new standards are included, and coverage of the preservation issues of dosage forms is widened to include semi-solids and liquid preparations. This edition also contains new regulations regarding preservative efficacy testing and covers pharmacopoeial and industry regulations and guidelines. Rapid methods are also discussed, now more common in cosmetic and toiletry practice, in their pharmaceutical capacity.
Download or read book Hugo and Russell s Pharmaceutical Microbiology written by Stephen P. Denyer and published by John Wiley & Sons. This book was released on 2008-04-15 with total page 494 pages. Available in PDF, EPUB and Kindle. Book excerpt: Completely revised and updated Pharmaceutical Microbiologycontinues to provide the essential resource for the 21st centurypharmaceutical microbiologist "....a valuable resource for junior pharmacists graspingan appreciation of microbiology, microbiologists entering thepharmaceutical field, and undergraduate pharmacy students." Journal of Antimicrobial Chemotherapy ".....highly readable. The content is comprehensive, withwell-produced tables, diagrams and photographs, and is accessiblethrough the extensive index." Journal of Medical Microbiology WHY BUY THIS BOOK? Completely revised and updated to reflect the rapid pace ofchange in the teaching and practice of pharmaceuticalmicrobiology Expanded coverage of modern biotechnology, including genomicsand recombinant DNA technology Updated information on newer antimicrobial agents and theirmode of action Highly illustrated with structural formulas of organiccompounds and flow diagrams of biochemical processes
Download or read book Quality Control written by and published by . This book was released on 1992 with total page pages. Available in PDF, EPUB and Kindle. Book excerpt:
Download or read book Performance driven Quality Control written by Zoe C. Brooks and published by Amer. Assoc. for Clinical Chemistry. This book was released on 2001 with total page 228 pages. Available in PDF, EPUB and Kindle. Book excerpt:
Download or read book Microbiology Laboratory Guidebook written by United States. Food Safety and Inspection Service. Microbiology Division and published by . This book was released on 1998 with total page 634 pages. Available in PDF, EPUB and Kindle. Book excerpt:
Download or read book Clinical Microbiology Procedures Handbook written by and published by John Wiley & Sons. This book was released on 2020-08-06 with total page 2954 pages. Available in PDF, EPUB and Kindle. Book excerpt: 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.
Download or read book The Evaluation of Forensic DNA Evidence written by National Research Council and published by National Academies Press. This book was released on 1996-12-12 with total page 270 pages. Available in PDF, EPUB and Kindle. Book excerpt: In 1992 the National Research Council issued DNA Technology in Forensic Science, a book that documented the state of the art in this emerging field. Recently, this volume was brought to worldwide attention in the murder trial of celebrity O. J. Simpson. The Evaluation of Forensic DNA Evidence reports on developments in population genetics and statistics since the original volume was published. The committee comments on statements in the original book that proved controversial or that have been misapplied in the courts. This volume offers recommendations for handling DNA samples, performing calculations, and other aspects of using DNA as a forensic toolâ€"modifying some recommendations presented in the 1992 volume. The update addresses two major areas: Determination of DNA profiles. The committee considers how laboratory errors (particularly false matches) can arise, how errors might be reduced, and how to take into account the fact that the error rate can never be reduced to zero. Interpretation of a finding that the DNA profile of a suspect or victim matches the evidence DNA. The committee addresses controversies in population genetics, exploring the problems that arise from the mixture of groups and subgroups in the American population and how this substructure can be accounted for in calculating frequencies. This volume examines statistical issues in interpreting frequencies as probabilities, including adjustments when a suspect is found through a database search. The committee includes a detailed discussion of what its recommendations would mean in the courtroom, with numerous case citations. By resolving several remaining issues in the evaluation of this increasingly important area of forensic evidence, this technical update will be important to forensic scientists and population geneticistsâ€"and helpful to attorneys, judges, and others who need to understand DNA and the law. Anyone working in laboratories and in the courts or anyone studying this issue should own this book.
