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||: Nirali Prakashan|
|ISBN 10||: 9788185790619|
|Pages||: 329 pages|
Pharmaceutical microbiology has a bearing on all aspects of pharmacy, from the manufacture and quality control of pharmaceutical products through to an understanding of the mode of action of antibiotics. Fully revised and restructured, drawing on the contributions of subject experts, and including material relevant to the European curricula in pharmacy, the eighth edition covers: biology of micro-organisms pathogens and host response prescribing therapeutics contamination and infection control pharmaceutical production current trends and new directions Hugo and Russell’s Pharmaceutical Microbiology, a standard text for Schools of Pharmacy for seven editions, continues to be a user-friendly and authoritative guide for both students and practitioners of pharmacy and pharmaceutical microbiology. 'Highly Commended' in the Pharmacology section of the 2012 BMA Book Awards
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.
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||: Ravi Kumar Maddali|
|Publisher||: Pharmamed Press|
|Release Date||: 2019-09-17|
|ISBN 10||: 9789386819666|
|Pages||: 712 pages|
Pharmeceutical Microbiology is one of the important components in pharmaceutical sciences to prepare and maintain the sterile preparations, control the spoilage of drugs and to study the infectious diseases. To excel in pharmacy career students definitely need comprehensive knowledge and strong foundation in pharmaceutical microbiology subject. Many books are available on general microbiology subject but few books on pharmaceutical microbiology are available for students to choose. As a teacher having 25 years teaching experience in teaching pharmaceutical microbiology and biotechnology related subjects, I have tried to deal basic microbiology, control of microorganisms, immunology, bacterial genetics, microbiological assays, pharmaceutical applications of microorganisms, industrially important microorganisms, some important diseases and miscellaneous topic under this heading. My academic learning in pharmaceutical biotechnology at postgraduate level and Ph.D levels helped me a lot to deal different topics appropriately. Syllabi of all most all Indian Universities is covered thoroughly in this book in a clear and understandable manner, so students need not refer various books for various topics in this subject. Proper care is also taken to prevent the overlap of allied topics which are not appropriate to include in microbiology syllabus.
|Pages||: 329 pages|
|Author||: Geoff Hanlon,Norman A. Hodges|
|Publisher||: John Wiley & Sons|
|Release Date||: 2012-12-10|
|ISBN 10||: 1118432436|
|Pages||: 240 pages|
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.
Pharmaceutical Microbiology is an applied branch of Microbiology which deals with the study of microorganisms associated with manufacturing and quality control of pharmaceutical products. The present book "Pharmaceutical Microbiology: A Laboratory Manual" meets the syllabus designed by the Pharmacy Council of India and is written with a holistic approach encompassing various topics of Experimental Pharmaceutical Microbiology. This manual covers nearly 50 experiments based on General and Pharmaceutical Microbiology which would serve as a guide to B-Pharmacy students of all the Indian Universities. The main aim of writing this book is to cover theoretical and experimental parts of all the topics included in the curriculum for Experimental Pharmaceutical Microbiology given in the revised syllabus of B.Pharm students. The various concepts and phenomenon have been explained in simple terms with the help of appropriate diagrams. The experimental methods are tailor made to meet the modest facilities available in many of the colleges and universities within the country.
Pharmaceutical microbiology is a specialist area of microbiology and one concerned with the use of microorganisms in pharmaceutical development and with maintaining contamination control. This book 'Pharmaceutical Microbiology' provides knowledge and understanding with regards to the significance of the presence of bacteria, yeasts, moulds, viruses and toxins in pharmaceutical raw materials, intermediates, products and pharmaceutical production environments, as well as the microbiological control of pharmaceutical products, production environments and people. It provides the latest information on protecting pharmaceutical and healthcare products from spoilage by microorganisms, and protecting patients and consumers. 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. In addition, the book consists of several illustrations and diagrams for better understanding of the concepts. It is an encyclopedia of information for professionals and students of this field. This book brings together all relevant technologies new and existing ones. This book presents information in an easy-to-understand, accessible manner for students at every level. Readers, professionals, researchers and students will find this book valuable.