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Author: Society for Applied Bacteriology
Publisher:
ISBN:
Category :
Languages : en
Pages :
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Author: Society for Applied Bacteriology
Publisher:
ISBN:
Category :
Languages : en
Pages :
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Book Description
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: M. T. Saunders
Publisher:
ISBN:
Category :
Languages : en
Pages : 13
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Author: Institute of Food Science and Technology
Publisher: John Wiley & Sons
ISBN: 1118318234
Category : Technology & Engineering
Languages : en
Pages : 277
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Book Description
Good Manufacturing Practice (GMP) refers to advice and guidance put in place to outline the aspects of production and testing that can impact the quality and safety of a product. In the case of food and drink, GMP is aimed at ensuring that products are safe for the consumer and are consistently manufactured to a quality appropriate to their intended use. Manufacturers have for several years been driving towards such goals as Total Quality Management (TQM), lean manufacturing and sustainability – GMP is bound up with these issues. The ever-increasing interest amongst consumers, retailers and enforcement authorities in the conditions and practices in food manufacture and distribution, increases the need for the food manufacturer to operate within clearly defined policies such as those laid down in GMP. The ability to demonstrate that Good Manufacturing Practice has been fully and effectively implemented could, in the event of a consumer complaint or a legal action, reduce the manufacturer’s liability and protect them from prosecution. First launched in 1986, IFST’s Good Manufacturing Practice Guide has been widely recognized as an indispensable reference work for food scientists and technologists. It sets out to ensure that food manufacturing processes deliver products that are uniform in quality, free from defects and contamination, and as safe as it is humanly possible to make them. This 6th edition has been completely revised and updated to include all the latest standards and guidance, especially with regard to legislation-driven areas such as HACCP. The Guide is a must have for anyone in a managerial or technical capacity concerned with the manufacture, storage and distribution of food and drink. It is also a valuable reference for food education, training and for those involved in food safety and enforcement. Food scientists in academic and industry environments will value its precision, and policy makers and regulatory organizations will find it an indispensable guide to an important and multifaceted area. About IFST IFST is the leading independent qualifying body for food professionals in Europe and the only professional body in the UK concerned with all aspects of food science and technology. IFST members are drawn from all over the world and from all ages and backgrounds, including industry (manufacturing, retailing and food service), universities and schools, government, research and development, quality assurance and food law enforcement. IFST qualifications are internationally recognised as a sign of proficiency and integrity.
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: Michael M. Cramer
Publisher: CRC Press
ISBN: 1420005944
Category : Technology & Engineering
Languages : en
Pages : 299
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Book Description
Prevention of food borne illnesses, reduction of product spoilage, and improvements to product quality are ongoing concerns in the food manufacturing industry. Providing broad but practical information, Food Plant Sanitation: Design, Maintenance, and Good Manufacturing Practices shows how to effectively remove soil and microorganisms from the proce
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: Graham P. Bunn
Publisher: CRC Press
ISBN: 1498732070
Category : Medical
Languages : en
Pages : 371
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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.
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: 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
