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Author: David Roesti
Publisher: John Wiley & Sons
ISBN: 1119356075
Category : Technology & Engineering
Languages : en
Pages : 594
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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 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
ISBN: 1119356075
Category : Technology & Engineering
Languages : en
Pages : 594
Get Book Here
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 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: Stephen P. Denyer
Publisher: CRC Press
ISBN: 1420021621
Category : Science
Languages : en
Pages : 500
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Book Description
Microbiological matters continue to exercise considerable influence on product quality. In both the pharmaceutical and medical device industries, products of greater sophistication, along with evolving regulatory requirements, are elevating the challenges related to maintaining microbiological integrity. Updated to reflect technological and regulatory changes, the Guide to Microbiological Control in Pharmaceuticals and Medical Devices, Second Edition covers thoseprincipal aspects of microbiology that arerelevant to the preformulation, formulation, manufacturing, and license application stages involved with the production of pharmaceuticals and medical devices. In recognition of the diverse disciplines involved in pharmaceutical and medical device production, this work provides a brief introduction to microbiology geared towards the nonmicrobiologist. Covering good manufacturing practice in the control of contamination, the text explores quality control, the preservation of formulations, and principles of sterilization, including microbiological-specific considerations for biotechnological products and other medical devices. It also provides additional materials on package integrity and contamination risks in clean rooms. The editors have produced a companion text, the Handbook of Microbiological Quality Control in Pharmaceuticals and Medical Devices (see reverse), which when paired with the Guide offers a complete theoretical and practical treatment of microbiological control. This book provides a comprehensive distillation of information concerning methodology and regulations that would otherwise remain scattered throughout the literature. It allows scientists from many fields to address potential problems in advance and implement suitable strategies at the earliest stages of development.
Author: National Research Council
Publisher: National Academies Press
ISBN: 030908928X
Category : Medical
Languages : en
Pages : 425
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Book Description
Food safety regulators face a daunting task: crafting food safety performance standards and systems that continue in the tradition of using the best available science to protect the health of the American public, while working within an increasingly antiquated and fragmented regulatory framework. Current food safety standards have been set over a period of years and under diverse circumstances, based on a host of scientific, legal, and practical constraints. Scientific Criteria to Ensure Safe Food lays the groundwork for creating new regulations that are consistent, reliable, and ensure the best protection for the health of American consumers. This book addresses the biggest concerns in food safetyâ€"including microbial disease surveillance plans, tools for establishing food safety criteria, and issues specific to meat, dairy, poultry, seafood, and produce. It provides a candid analysis of the problems with the current system, and outlines the major components of the task at hand: creating workable, streamlined food safety standards and practices.
Author: Vesper
Publisher: David Horwood International Pub Limited
ISBN: 9781930114173
Category : Medical
Languages : en
Pages : 224
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Book Description
Author: Tim Sandle
Publisher: Elsevier
ISBN: 0443216010
Category : Medical
Languages : en
Pages : 510
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Book Description
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: Richard Chin
Publisher: Elsevier
ISBN: 0080557937
Category : Medical
Languages : en
Pages : 560
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Book Description
Clinical trials are an important part of medicine and healthcare today, deciding which treatments we use to treat patients. Anyone involved in healthcare today must know the basics of running and interpreting clinical trial data. Written in an easy-to-understand style by authors who have considerable expertise and experience in both academia and industry, Principles and Practice of Clinical Trial Medicine covers all of the basics of clinical trials, from legal and ethical issues to statistics, to patient recruitment and reporting results. - Jargon-free writing style enables those with less experience to run their own clinical trials and interpret data - Book contains an ideal mix of theory and practice so researchers will understand both the rationale and logistics to clinical trial medicine - Expert authorship whose experience includes running clinical trials in an academic as well as industry settings - Numerous illustrations reinforce and elucidate key concepts and add to the book's overall pedagogy
Author: Rosamund M. Baird
Publisher: CRC Press
ISBN: 0203305191
Category : Medical
Languages : en
Pages : 274
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Book Description
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: Graham P. Bunn
Publisher: CRC Press
ISBN: 1498732070
Category : Medical
Languages : en
Pages : 387
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Book Description
This book provides insight into the world of pharmaceutical quality systems and the key elements that must be in place to change the business and organizational dynamics from task-oriented procedure-based cultures to truly integrated quality business systems that are self-detecting and correcting. Chapter flow has been changed to adopt a quality systems organization approach, and supporting chapters have been updated based on current hot topics including the impact of the worldwide supply chain complexity and current regulatory trends. Key Features: Presents insight into the world of pharmaceutical quality systems Analyzes regulatory trends and expectations Includes approaches and practices used in the industry to comply with regulatory requirements Discusses recent worldwide supply chain issues Delivers valuable information to a worldwide audience regarding the current GMP practices in the industry
Author: Michael M. Cramer
Publisher: CRC Press
ISBN: 1466511737
Category : Technology & Engineering
Languages : en
Pages : 309
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Book Description
Food safety and quality are primary concerns in the food manufacturing industry. Written by an author with more than 35 years’ experience in the food industry, Food Plant Sanitation: Design, Maintenance, and Good Manufacturing Practices, Second Edition provides completely updated practical advice on all aspects of food plant sanitation and sanitation-related food safety issues. It offers readers the tools to establish a food safety system to help control microbiological, physical, and chemical hazards. Understanding that sanitation is integral to food safety is the foundation for an effective food safety system. Beginning with that premise, this book presents some of the key components for such a system. The chapters address testing for and control of microorganisms in food manufacturing, including recent challenges in the industry due to pathogens such as Listeria monocytogenes. They also offer discussions on biofilms, regulatory requirements from the European Union, allergens, sanitary facility design, and describe proven best practices for sanitation as well as current sanitary requirements and regulatory changes from the FDA and USDA. In addition, the author presents methods for verifying sanitation. The final chapters identify good manufacturing practices for employees and present a comprehensive pest management plan, including control measures and chemical interventions. The book concludes with strategies for preventing chemical and physical food safety hazards. This reference provides a practical perspective for implementing food plant sanitation and safety processes. The author has included, wherever possible, examples of procedures, forms, and documents to help novice food safety and quality professionals develop effective food safety systems.
Author: Tim Sandle
Publisher: Woodhead Publishing
ISBN: 0081000448
Category : Science
Languages : en
Pages : 318
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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
