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Pharmaceutical Microbiological Quality Assurance and Control

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Release : 2020-01-02
Genre : Technology & Engineering
Kind : eBook
Book Rating : 075/5 ( reviews)

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Book Synopsis Pharmaceutical Microbiological Quality Assurance and Control by : David Roesti

Download or read book Pharmaceutical Microbiological Quality Assurance and Control written by David Roesti. This book was released on 2020-01-02. Available in PDF, EPUB and Kindle. Book excerpt: 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

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Release : 2015-10-09
Genre : Science
Kind : eBook
Book Rating : 448/5 ( reviews)

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Book Synopsis Pharmaceutical Microbiology by : Tim Sandle

Download or read book Pharmaceutical Microbiology written by Tim Sandle. This book was released on 2015-10-09. Available in PDF, EPUB and Kindle. Book excerpt: 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

Handbook of Microbiological Quality Control in Pharmaceuticals and Medical Devices

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Release : 2000-08-17
Genre : Medical
Kind : eBook
Book Rating : 191/5 ( reviews)

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Book Synopsis Handbook of Microbiological Quality Control in Pharmaceuticals and Medical Devices by : Rosamund M. Baird

Download or read book Handbook of Microbiological Quality Control in Pharmaceuticals and Medical Devices written by Rosamund M. Baird. This book was released on 2000-08-17. Available in PDF, EPUB and Kindle. Book excerpt: 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

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Release : 2017-12-14
Genre : Science
Kind : eBook
Book Rating : 630/5 ( reviews)

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Book Synopsis Microbial Quality Assurance in Pharmaceuticals, Cosmetics, and Toiletries by : R. Baird

Download or read book Microbial Quality Assurance in Pharmaceuticals, Cosmetics, and Toiletries written by R. Baird. This book was released on 2017-12-14. Available in PDF, EPUB and Kindle. Book excerpt: 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.

Microbial Quality Assurance in Pharmaceuticals, Cosmetics, and Toiletries

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Author :
Release : 2017-12-14
Genre : Science
Kind : eBook
Book Rating : 622/5 ( reviews)

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Book Synopsis Microbial Quality Assurance in Pharmaceuticals, Cosmetics, and Toiletries by : R. Baird

Download or read book Microbial Quality Assurance in Pharmaceuticals, Cosmetics, and Toiletries written by R. Baird. This book was released on 2017-12-14. Available in PDF, EPUB and Kindle. Book excerpt: 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.

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