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 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 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 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 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 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 Quality Assurance in Bacteriology and Immunology written by Who Regional Office for South-East Asia and published by WHO Regional Publications Sout. This book was released on 2012-07-06 with total page 0 pages. Available in PDF, EPUB and Kindle. Book excerpt: There is an increasing dependence on clinical and public health laboratories for better patient management and also for preventing the spread of emerging pathogens. With rapid and significant growth of laboratories at all levels of health care, it has become mandatory to check results to make them reliable and cost-effective, as well as comparable with those obtained by international laboratories. The International Standards Organization (ISO) has provided several guidelines and standards for achieving quality in laboratory results. These guidelines dwell upon the basic concepts of quality assurance in microbiology and also describe essential practices and steps of ensuring quality in various activities that a microbiology laboratory is expected to undertake in its support to primary health care system in a biosafe environment and in accordance with ISO. Following these guidelines will help in delivery of reliable, cost-effective and timely laboratory results and support clinical and public health actions.
Download or read book Quality Assurance in Microbiology written by Quality Assurance In Microbiology and published by . This book was released on 1995-02-01 with total page pages. Available in PDF, EPUB and Kindle. Book excerpt:
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 2017-12-14 with total page 272 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 Microbiological Safety and Quality of Food written by Barbara M. Lund and published by Springer Science & Business Media. This book was released on 2000 with total page 1080 pages. Available in PDF, EPUB and Kindle. Book excerpt: This authoritative two-volume reference provides valuable, necessary information on the principles underlying the production of microbiologically safe and stable foods. The work begins with an overview and then addresses four major areas: 'Principles and application of food preservation techniques' covers the specific techniques that defeat growth of harmful microorganisms, how those techniques work, how they are used, and how their effectiveness is measured. 'Microbial ecology of different types of food' provides a food-by-food accounting of food composition, naturally occurring microflora, effects of processing, how spoiling can occur, and preservation. 'Foodborne pathogens' profiles the most important and the most dangerous microorganisms that can be found in foods, including bacteria, viruses, parasites, mycotoxins, and 'mad cow disease.' The section also looks at the economic aspects and long-term consequences of foodborne disease. 'Assurance of the microbiological safety and quality of foods' scrutinizes all aspects of quality assurance, including HACCP, hygienic factory design, methods of detecting organisms, risk assessment, legislation, and the design and accreditation of food microbiology laboratories. Tables, photographs, illustrations, chapter-by-chapter references, and a thorough index complete each volume. This reference is of value to all academic, research, industrial and laboratory libraries supporting food programs; and all institutions involved in food safety, microbiology and food microbiology, quality assurance and assessment, food legislation, and generally food science and technology.
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 Quality Assurance for Microbiology in Feed Analysis Laboratories written by Richard A. Cowie and published by Food & Agriculture Organization of the UN (FAO). This book was released on 2013 with total page 0 pages. Available in PDF, EPUB and Kindle. Book excerpt: The adoption of the practices and procedures in the manual will assist microbiology laboratories in acquiring the recognition of competence required for certification or accreditation and will also enhance the quality of the microbiological data generated by feed analysis laboratories. In addition, ensuring good laboratory practices presented in the document will enhance the health and safety of the laboratory workers, protect the environment from laboratory-discharged pollutants and increase the efficiency of laboratories. The document will also provide a strong base for microbiology laboratories on which they can develop a system which will meet the requirements of international standards.
Download or read book Quality Assurance Principles and Practice in the Microbiology Laboratory written by Great Britain. Public Health Laboratory Service and published by . This book was released on 1999-01-01 with total page 328 pages. Available in PDF, EPUB and Kindle. Book excerpt:
Download or read book Clinical Microbiology written by Charles W Stratton, MD and published by Demos Medical Publishing. This book was released on 2011-07-10 with total page 164 pages. Available in PDF, EPUB and Kindle. Book excerpt: About the Diagnostic Standards of Care Series A key issue for every laboratory and individual laboratory practitioner is the assessment of risk and a current working knowledge of the standards of care established for diagnostic testing via guidelines, major studies and trials. The Diagnostic Standards of Care series presents an overview of the key diagnoses in clinical pathology using case examples to illustrate effective analysis of the case in light of current evidence and standards for the problem discussed. In addition to being practical diagnostic guides, these volumes will have a unique emphasis on quality assurance and evidence-based testing practices and the role of the pathologist in ensuring quality and patient safety. Clinical Microbiology addresses common medical errors seen in the clinical microbiology laboratory in order to show these errors to pathologists and laboratory technicians as well as clinicians. The goal is to allow such errors to be corrected by both individual effort and a systems approach in the laboratory. The book addresses potential medical errors in test ordering and specimen collection, testing in the laboratory, and reporting and interpretation of test results. Each of these phases can have an adverse impact on the diagnosis and treatment of an infectious disease if a medical error occurs. Potential medical errors are described and discussed in a clinical case-based learning format to effectively illustrate the conditions that contribute to these errors and enable the reader to recognize and avoid them in daily practice. Clinical Microbiology Features Descriptions of potential errors in test ordering and specimen collection in clinical microbiology Descriptions of potential errors in test performance in clinical microbiology Descriptions of potential errors in test reporting and interpretation in clinical microbiology Clinical case discussions provide "real world" illustrations of potential errors and how to anticipate and avoid them in practice Is pocket-sized for portability
Download or read book Microbiological Analysis of Red Meat Poultry and Eggs written by G Mead and published by Woodhead Publishing. This book was released on 2006-11-30 with total page 365 pages. Available in PDF, EPUB and Kindle. Book excerpt: Red meat, poultry and eggs are, or have been, major global causes of foodborne disease in humans and are also prone to microbiological growth and spoilage. Consequently, monitoring the safety and quality of these products remains a primary concern. Microbiological analysis is an established tool in controlling the safety and quality of foods. Recent advances in preventative and risk-based approaches to food safety control have reinforced the role of microbiological testing of foods in food safety management. In a series of chapters written by international experts, the key aspects of microbiological analysis, such as sampling methods, use of faecal indicators, current approaches to testing of foods, detection and enumeration of pathogens and microbial identification techniques, are described and discussed. Attention is also given to the validation of analytical methods and Quality Assurance in the laboratory. Because of their present importance to the food industry, additional chapters on current and developing legislation in the European Union and the significance of Escherichia coli 0157 and other VTEC are included. Written by a team of international experts, Microbiological analysis of red meat, poultry and eggs is certain to become a standard reference in the important area of food microbiology. Reviews key issues in food microbiology Discusses key aspects of microbiological analysis such as sampling methods, detection and enumeration of pathogens Includes chapters on the validation on analytical methods and quality assurance in the laboratory
Download or read book Statistical Aspects of the Microbiological Examination of Foods written by Basil Jarvis and published by Academic Press. This book was released on 2016-07-12 with total page 354 pages. Available in PDF, EPUB and Kindle. Book excerpt: 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
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 2017-12-14 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.
