Pharmaceutical Microbiology

Pharmaceutical Microbiology
Author: Tim Sandle
Publsiher: Woodhead Publishing
Total Pages: 316
Release: 2015-10-09
Genre: Science
ISBN: 9780081000441

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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

Hugo and Russell s Pharmaceutical Microbiology

Hugo and Russell s Pharmaceutical Microbiology
Author: Stephen P. Denyer,Norman A. Hodges,Sean P. Gorman
Publsiher: John Wiley & Sons
Total Pages: 494
Release: 2008-04-15
Genre: Medical
ISBN: 9781405141031

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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

Pharmaceutical Microbiology
Author: Reddy, Venkateswara A./ Jayaveera K.N. & Sreenivasulu V.
Publsiher: S. Chand Publishing
Total Pages: 188
Release: 2024
Genre: Medical
ISBN: 9788121942461

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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 Microbiological Quality Assurance and Control

Pharmaceutical Microbiological Quality Assurance and Control
Author: David Roesti,Marcel Goverde
Publsiher: John Wiley & Sons
Total Pages: 594
Release: 2020-01-02
Genre: Technology & Engineering
ISBN: 9781119356073

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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

Pharmaceutical Microbiology Manual

Pharmaceutical Microbiology Manual
Author: United States Food and Drug Administration
Publsiher: Createspace Independent Publishing Platform
Total Pages: 92
Release: 2017-09-21
Genre: Electronic Book
ISBN: 1976578671

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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.

Microbiology in Pharmaceutical Manufacturing

Microbiology in Pharmaceutical Manufacturing
Author: Richard Ed Prince
Publsiher: Parenteral Drug Association
Total Pages: 593
Release: 2008
Genre: Medical
ISBN: 1933722193

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A Textbook Of Pharmaceutical Microbiology

A Textbook Of Pharmaceutical Microbiology
Author: Prahlad Singh Mehra
Publsiher: Unknown
Total Pages: 240
Release: 2011-04-01
Genre: Pharmaceutical microbiology
ISBN: 9381141118

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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

Handbook of Microbiological Quality Control in Pharmaceuticals and Medical Devices

Handbook of Microbiological Quality Control in Pharmaceuticals and Medical Devices
Author: Rosamund M. Baird,Norman A. Hodges,Stephen P. Denyer
Publsiher: CRC Press
Total Pages: 274
Release: 2000-08-17
Genre: Medical
ISBN: 9780203305195

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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