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| Author | : David Roesti |
| Publisher | : John Wiley & Sons |
| Total Pages | : 594 |
| Release | : 2020-01-02 |
| Genre | : Technology & Engineering |
| ISBN | : 1119356075 |
Download Pharmaceutical Microbiological Quality Assurance and Control Book in PDF, ePub and Kindle
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 Roesti |
| Publisher | : John Wiley & Sons |
| Total Pages | : 511 |
| Release | : 2019-12-02 |
| Genre | : Technology & Engineering |
| ISBN | : 1119356121 |
Download Pharmaceutical Microbiological Quality Assurance and Control Book in PDF, ePub and Kindle
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
| Author | : David Roesti |
| Publisher | : John Wiley & Sons |
| Total Pages | : 592 |
| Release | : 2019-11-12 |
| Genre | : Technology & Engineering |
| ISBN | : 1119356113 |
Download Pharmaceutical Microbiological Quality Assurance and Control Book in PDF, ePub and Kindle
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 | : Tim Sandle |
| Publisher | : Woodhead Publishing |
| Total Pages | : 316 |
| Release | : 2015-10-09 |
| Genre | : Science |
| ISBN | : 0081000448 |
Download Pharmaceutical Microbiology Book in PDF, ePub and Kindle
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 | : Rosamund M. Baird |
| Publisher | : CRC Press |
| Total Pages | : 274 |
| Release | : 2000-08-17 |
| Genre | : Medical |
| ISBN | : 0203305191 |
Download Handbook of Microbiological Quality Control in Pharmaceuticals and Medical Devices Book in PDF, ePub and Kindle
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
| Author | : R. Baird |
| Publisher | : CRC Press |
| Total Pages | : 272 |
| Release | : 2017-12-14 |
| Genre | : Science |
| ISBN | : 1135743630 |
Download Microbial Quality Assurance in Pharmaceuticals, Cosmetics, and Toiletries Book in PDF, ePub and Kindle
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.
| Author | : Nigel Halls |
| Publisher | : CRC Press |
| Total Pages | : 198 |
| Release | : 2016-04-19 |
| Genre | : Medical |
| ISBN | : 1420025805 |
Download Microbiological Contamination Control in Pharmaceutical Clean Rooms Book in PDF, ePub and Kindle
Contamination control in pharmaceutical clean rooms has developed from a jumble of science and engineering, knowledge of what has worked well or badly in the past, dependent upon the technology available at the time the clean room was built and subsequent technological developments. Surrounding it all is a blanket of regulations. Taking a multidisc
| Author | : Tim Sandle |
| Publisher | : Elsevier |
| Total Pages | : 510 |
| Release | : 2024-02-09 |
| Genre | : Medical |
| ISBN | : 0443216010 |
Download Biocontamination Control for Pharmaceuticals and Healthcare Book in PDF, ePub and Kindle
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 | : R. Baird |
| Publisher | : CRC Press |
| Total Pages | : 311 |
| Release | : 2017-12-14 |
| Genre | : Science |
| ISBN | : 1135743622 |
Download Microbial Quality Assurance in Pharmaceuticals, Cosmetics, and Toiletries Book in PDF, ePub and Kindle
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.
| Author | : Scott Sutton |
| Publisher | : |
| Total Pages | : 0 |
| Release | : 2007 |
| Genre | : Pharmaceutical industry |
| ISBN | : 9781933722085 |
Download Pharmaceutical Quality Control Microbiology Book in PDF, ePub and Kindle
