Pharmaceutical Microbiological Quality Assurance and Control


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




Microbiological Analysis of Food and Water


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).




Handbook of Microbiological Quality Control in Pharmaceuticals and Medical Devices


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




Microbial Quality Assurance in Pharmaceuticals, Cosmetics, and Toiletries


Book Description

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.




Microbiological Safety and Quality of Food


Book Description

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.




The Microbiological Quality of Food


Book Description

The Microbiological Quality of Food: Foodborne Spoilers covers the microbiological spoilage of foods, with a focus on the spoilers, the foods themselves, and the signs of spoilage. The book addresses traditional spoilers (filamentous fungi, spore-forming bacteria, yeasts, SSO in fish), as well as some emerging spoilers (Pseudomonas), now recognized as primary targets. Sections also provide a brief overview of important foods (vegetables, milk and dairy products, meat, and fish) and addresses safety and economic loss. Details on the signs of spoilage, how to prevent spoilers, and methods of detecting spoilage and spoilage microorganisms in foods are also presented. This is an authoritative reference for researchers, scientists and students who need to understand microbial spoilage, the impact of biofilm on the quality and safety of many foods, and the implications of biofilm for spoilage and shelf life. Hot topics covered by this book include the possible link between food spoilage and food safety as a consequence of antibiotic resistance spreading all over the world. - Presents Definitions: taxonomy, definition of food spoilage according to the literature and regulatory frameworks - Provides Case Studies: for some foods and emerging spoilers, along with examples of how to prolong the shelf life - Includes Calculations/worked examples: models and practical examples to calculate the shelf life of foods and to design and effective method to inhibit spoilers




Quality Assurance for Microbiology in Feed Analysis Laboratories


Book Description

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.




Pharmaceutical Microbiology


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




Clinical Microbiology Procedures Handbook


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. If you are looking for online access to the latest from this reference or site access for your lab, please visit www.wiley.com/learn/clinmicronow.




Statistical Aspects of the Microbiological Examination of Foods


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