Author: Stephen P. Denyer
Publisher: John Wiley & Sons
ISBN: 1405141034
Category : Medical
Languages : en
Pages : 494
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
Hugo and Russell's Pharmaceutical Microbiology
Author: Stephen P. Denyer
Publisher: John Wiley & Sons
ISBN: 1405141034
Category : Medical
Languages : en
Pages : 494
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
Publisher: John Wiley & Sons
ISBN: 1405141034
Category : Medical
Languages : en
Pages : 494
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
Pharmaceutical Microbiology
Author: Tim Sandle
Publisher: Woodhead Publishing
ISBN: 0081000448
Category : Science
Languages : en
Pages : 318
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
Publisher: Woodhead Publishing
ISBN: 0081000448
Category : Science
Languages : en
Pages : 318
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
Essential Microbiology for Pharmacy and Pharmaceutical Science
Author: Geoff Hanlon
Publisher: John Wiley & Sons
ISBN: 1118432436
Category : Science
Languages : en
Pages : 336
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.
Publisher: John Wiley & Sons
ISBN: 1118432436
Category : Science
Languages : en
Pages : 336
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.
A Textbook Of Pharmaceutical Microbiology
Author: Prahlad Singh Mehra
Publisher:
ISBN: 9789381141113
Category : Pharmaceutical microbiology
Languages : en
Pages : 240
Book Description
Textbook of Pharmaceutical Mircobiology is an attempt to make each chapter independent and self-contained. This book is very important and essential for every pharmacy student because it s direct connection with pharmaceutical industry, particularly in ma
Publisher:
ISBN: 9789381141113
Category : Pharmaceutical microbiology
Languages : en
Pages : 240
Book Description
Textbook of Pharmaceutical Mircobiology is an attempt to make each chapter independent and self-contained. This book is very important and essential for every pharmacy student because it s direct connection with pharmaceutical industry, particularly in ma
Pharmaceutical Microbiology Manual
Author: United States Food and Drug Administration
Publisher: Createspace Independent Publishing Platform
ISBN: 9781976578670
Category :
Languages : en
Pages : 92
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.
Publisher: Createspace Independent Publishing Platform
ISBN: 9781976578670
Category :
Languages : en
Pages : 92
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.
Pharmaceutical Microbiological Quality Assurance and Control
Author: David Roesti
Publisher: John Wiley & Sons
ISBN: 1119356075
Category : Technology & Engineering
Languages : en
Pages : 594
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
Publisher: John Wiley & Sons
ISBN: 1119356075
Category : Technology & Engineering
Languages : en
Pages : 594
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
Pharmaceutical Microbiology
Author: Reddy, Venkateswara A./ Jayaveera K.N. & Sreenivasulu V.
Publisher: S. Chand Publishing
ISBN: 8121942462
Category : Medical
Languages : en
Pages : 188
Book Description
This book covers the syllabi of all Indian universities and competitive exams (GATE & GPAT). The book covers the major courses in Indian and abroad degrees such as B.Pharm., M.Pharm., B.Tech., M.Tech., M.Sc. (Microbiology, Biotechnology, Biochemistry, Food Microbiology, Pathology, and other Life Sciences) and B.Sc.(Life Sciences).
Publisher: S. Chand Publishing
ISBN: 8121942462
Category : Medical
Languages : en
Pages : 188
Book Description
This book covers the syllabi of all Indian universities and competitive exams (GATE & GPAT). The book covers the major courses in Indian and abroad degrees such as B.Pharm., M.Pharm., B.Tech., M.Tech., M.Sc. (Microbiology, Biotechnology, Biochemistry, Food Microbiology, Pathology, and other Life Sciences) and B.Sc.(Life Sciences).
Pharmaceutical Microbiology
Author: Dr. C. R. Kokare
Publisher:
ISBN: 9788188739493
Category :
Languages : en
Pages : 0
Book Description
Topics 1. Introduction 2. Study Of Laboratory Equipments 3. Bacterial Staining And Motility 4. Culture Media And Aseptic Transfer 5. Pure Culture Techniques 6. Counting Techniques Of Microorganisms 7. Cultivation Of Microorganisms: Physical Requirements 8. Selective Media And Specific Growth Characteristics 9. Biochemical Activities 10.Control Of Microbial Growth 11. Actinomycetes 12. Fungi 13. Microbial Sgudy Of Water, Soil, Food And Air 14. Microbial Limit Tests 15. Tests For Sterility 16. Microbial Assay Includes Colour Pages of Plates - 6
Publisher:
ISBN: 9788188739493
Category :
Languages : en
Pages : 0
Book Description
Topics 1. Introduction 2. Study Of Laboratory Equipments 3. Bacterial Staining And Motility 4. Culture Media And Aseptic Transfer 5. Pure Culture Techniques 6. Counting Techniques Of Microorganisms 7. Cultivation Of Microorganisms: Physical Requirements 8. Selective Media And Specific Growth Characteristics 9. Biochemical Activities 10.Control Of Microbial Growth 11. Actinomycetes 12. Fungi 13. Microbial Sgudy Of Water, Soil, Food And Air 14. Microbial Limit Tests 15. Tests For Sterility 16. Microbial Assay Includes Colour Pages of Plates - 6
Microbial Limit and Bioburden Tests
Author: Lucia Clontz
Publisher: CRC Press
ISBN: 1420053493
Category : Medical
Languages : en
Pages : 344
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
Publisher: CRC Press
ISBN: 1420053493
Category : Medical
Languages : en
Pages : 344
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
Cleanroom Microbiology for the Non-Microbiologist
Author: David M. Carlberg
Publisher: CRC Press
ISBN: 9780935184730
Category : Medical
Languages : en
Pages : 168
Book Description
Written for the professional who has an immediate need for the information but has little or no training in the subject, Cleanroom Microbiology for the Non-Microbiologist introduces principles of microbiology. It explains the consequences of microbiological contamination, what contamination is all about, how microorganisms grow, and how they can be controlled. The book introduces the vocabulary of microbiology and the types, sources, control, and elimination of organisms encountered in the manufacture of sterile products. Beginning with a discussion of the various types of organisms, the text then covers applications for bacterial detection, avoidance of contamination, cleanroom design considerations, and validation of disinfection methods. This book is especially relevant for supervisors and managers who need a sound understanding of contamination control and is particularly effective for use in training. It also is an excellent resource for validation engineers, quality assurance and non-microbiologist quality-control staff, maintenance personnel, and process development staff.
Publisher: CRC Press
ISBN: 9780935184730
Category : Medical
Languages : en
Pages : 168
Book Description
Written for the professional who has an immediate need for the information but has little or no training in the subject, Cleanroom Microbiology for the Non-Microbiologist introduces principles of microbiology. It explains the consequences of microbiological contamination, what contamination is all about, how microorganisms grow, and how they can be controlled. The book introduces the vocabulary of microbiology and the types, sources, control, and elimination of organisms encountered in the manufacture of sterile products. Beginning with a discussion of the various types of organisms, the text then covers applications for bacterial detection, avoidance of contamination, cleanroom design considerations, and validation of disinfection methods. This book is especially relevant for supervisors and managers who need a sound understanding of contamination control and is particularly effective for use in training. It also is an excellent resource for validation engineers, quality assurance and non-microbiologist quality-control staff, maintenance personnel, and process development staff.