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Author: Tim Sandle
Publisher: Woodhead Publishing
ISBN: 0081000448
Category : Science
Languages : en
Pages : 318
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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: 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: 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: David B. Wilson
Publisher: John Wiley & Sons
ISBN: 3527340351
Category : Science
Languages : en
Pages : 418
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Book Description
Focusing on current and future uses of microbes as production organisms, this practice-oriented textbook complements traditional texts on microbiology and biotechnology. The editors have brought together leading researchers and professionals from the entire field of industrial microbiology and together they adopt a modern approach to a well-known subject. Following a brief introduction to the technology of microbial processes, the twelve most important application areas for microbial technology are described, from crude bulk chemicals to such highly refined biomolecules as enzymes and antibodies, to the use of microbes in the leaching of minerals and for the treatment of municipal and industrial waste. In line with their application-oriented topic, the authors focus on the "translation" of basic research into industrial processes and cite numerous successful examples. The result is a first-hand account of the state of the industry and the future potential for microbes in industrial processes. Interested students of biotechnology, bioengineering, microbiology and related disciplines will find this a highly useful and much consulted companion, while instructors can use the case studies and examples to add value to their teaching.
Author: Geoff Hanlon
Publisher: John Wiley & Sons
ISBN: 1118432436
Category : Science
Languages : en
Pages : 336
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Book Description
This text is an essential study guide for undergraduates studying microbiology modules on degree courses in pharmacy and the pharmaceutical sciences. Written by two pharmacists each with over 30 years experience of teaching, research and publishing in pharmaceutical microbiology, it distills the subject down into the essential elements that pharmacists and pharmaceutical scientists need to know in order to practice their profession, and it covers all the microbiology components of the Royal Pharmaceutical Society's indicative syllabus that is at the heart of every UK pharmacy degree. Much of the applied microbiology that a pharmacist or pharmaceutical scientist needs to know is unique: topics like the manufacture of microbiologically sterile medicines and their subsequent protection against microbial contamination and spoilage, the detection of hazardous microorganisms in medicines and antibiotics' manufacture and assay are all covered here. Essential Microbiology for Pharmacy and Pharmaceutical Science Students displays material in an easy to-digest format and concepts are explained using diagrams, tables and pictures wherever possible. The book contains an extensive self-assessment section that includes typical multiple choice, short answer and essay-style examination questions, and a companion website to further test your knowledge from a selection of questions along with further links to relevant sites.
Author: Heinrich Klefenz
Publisher: Wiley-VCH
ISBN:
Category : Medical
Languages : de
Pages : 328
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Book Description
This volume focuses on pharmaceutical biotechnology as a key area of life sciences. The complete range of concepts, processes and technologies of biotechnology is applied in modern industrial pharmaceutical research, development and production. The results of genome sequencing and studies of biological-genetic function are combined with chemical, micro-electronic and microsystem technology to produce medical devices and diagnostic biochips. A multitude of biologically active molecules is expanded by additional novel structures created with newly arranged gene clusters and bio-catalytic chemical processes. New organisational structures in the co-operation of institutes, companies and networks enable faster knowledge and product development and immediate application of the results of research and process development. This book is the ideal source of information for scientists and engineers in research and development, for decision-makers in biotech, pharma and chemical corporations, as well as for research institutes, but also for founders of biotech companies and people working for venture capital corporations.
Author: Tim Sandle
Publisher: Elsevier
ISBN: 0443216010
Category : Medical
Languages : en
Pages : 510
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Book Description
Biocontamination Control for Pharmaceuticals and Healthcare outlines a biocontamination strategy that tracks bio-burden control and reduction at each transition in classified areas of a facility. The first edition of the book covered many of the aspects of the strategy, but the new official guidance signals that a roadmap is required to fully comply with its requirements. Completely updated with the newest version of the EU-GPM (EN17141) the new edition expands the coverage of quality risk management and new complete examples to help professionals bridge the gap between regulation and implementation. Biocontamination Control for Pharmaceuticals and Healthcare offers professionals in pharma quality control and related areas guidance on building a complete biocontamination strategy. - Includes the most current regulations - Contains three new chapters, including Application of Quality Risk Management and its Application in Biocontamination Control, Designing an Environmental Monitoring Programme, and Synthesis: An Anatomy of a Contamination Control Strategy - Offers practical guidance on building a complete biocontamination strategy
Author: United States Food and Drug Administration
Publisher: Createspace Independent Publishing Platform
ISBN: 9781976578670
Category :
Languages : en
Pages : 92
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Book Description
Manual and is a supplement to the United States Pharmacopeia (USP) for pharmaceutical microbiology testing, including antimicrobial effectiveness testing, microbial examination of non-sterile products, sterility testing, bacterial endotoxin testing, particulate matter, device bioburden and environmental monitoring testing. The goal of this manual is to provide an ORA/CDER harmonized framework on the knowledge, methods and tools needed, and to apply the appropriate scientific standards required to assess the safety and efficacy of medical products within FDA testing laboratories. The PMM has expanded to include some rapid screening techniques along with a new section that covers inspectional guidance for microbiologists that conduct team inspections. This manual was developed by members of the Pharmaceutical Microbiology Workgroup and includes individuals with specialized experience and training. The instructions in this document are guidelines for FDA analysts. When available, analysts should use procedures and worksheets that are standardized and harmonized across all ORA field labs, along with the PMM, when performing analyses related to product testing of pharmaceuticals and medical devices. When changes or deviations are necessary, documentation should be completed per the laboratory's Quality Management System. Generally, these changes should originate from situations such as new products, unusual products, or unique situations. This manual was written to reduce compendia method ambiguity and increase standardization between FDA field laboratories. By providing clearer instructions to FDA ORA labs, greater transparency can be provided to both industry and the public. However, it should be emphasized that this manual is a supplement, and does not replace any information in USP or applicable FDA official guidance references. The PMM does not relieve any person or laboratory from the responsibility of ensuring that the methods being employed from the manual are fit for use, and that all testing is validated and/or verified by the user. The PMM will continually be revised as newer products, platforms and technologies emerge or any significant scientific gaps are identified with product testing. Reference to any commercial materials, equipment, or process in the PMM does not in any way constitute approval, endorsement, or recommendation by the U.S. Food and Drug Administration.
Author: Stephen P. Denyer
Publisher: John Wiley & Sons
ISBN: 1405141034
Category : Medical
Languages : en
Pages : 494
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Book Description
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
Author: Martin C. Easter
Publisher: CRC Press
ISBN: 0203010876
Category : Medical
Languages : en
Pages : 197
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Book Description
In recent years there has been increased interest in the possibility of rapid microbiological methods offering enhanced potential error detection capabilities. However, these methods raise a number of questions, such as how to validate new methods, will they be accepted by the pharmacopoeias, and, most importantly, how will the regulators respond?
Author: Lucia Clontz
Publisher: CRC Press
ISBN: 1420053493
Category : Medical
Languages : en
Pages : 344
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Book Description
In recent years, the field of pharmaceutical microbiology has experienced numerous technological advances, accompanied by the publication of new and harmonized compendial methods. It is therefore imperative for those who are responsible for monitoring the microbial quality of pharmaceutical/biopharmaceutical products to keep abreast of the latest c
