Описание: Intends to define the area of pharmaceutical chemistry as distinct from medicinal chemistry. This book emphasizes on the physicochemical properties of drug molecules and, in so far as they are known, the way that these properties govern the interaction of the drug with its target.
Автор: Jacobs, Terry Название: Good Design Practices for GMP Pharmaceutical Facilities ISBN: 1032339969 ISBN-13(EAN): 9781032339962 Издательство: Taylor&Francis Рейтинг: Цена: 7808.00 р. Наличие на складе: Есть у поставщика Поставка под заказ.
Автор: Vesper, James L. Название: Quality and GMP Auditing ISBN: 0367400901 ISBN-13(EAN): 9780367400903 Издательство: Taylor&Francis Рейтинг: Цена: 10411.00 р. Наличие на складе: Есть у поставщика Поставка под заказ.
Описание: More than just a checklist of audit questions, this guidebook contains proven methods and techniques for performing effective audits. Completely covering the four key competencies essential for successful GMP audits, the book explores the rationale behind using audits as a quality tool and explains the audit cycle broken into five distinct phases. To focus the power of auditing on a particular situation, several different types of audits are presented, as are more than a dozen audit approaches with general questions to answer and specific items to examine. These tools help readers prepare checklists and standards so audits become more effective, consistent, and standardized.
Автор: Edik, Mustafa Название: GMP Audits in Pharmaceutical and Biotechnology Industries ISBN: 103225730X ISBN-13(EAN): 9781032257303 Издательство: Taylor&Francis Рейтинг: Цена: 21437.00 р. Наличие на складе: Есть у поставщика Поставка под заказ.
Автор: Thomas Catalano Название: Essential Elements for a GMP Analytical Chemistry Department ISBN: 1461476410 ISBN-13(EAN): 9781461476412 Издательство: Springer Рейтинг: Цена: 20516.00 р. Наличие на складе: Есть у поставщика Поставка под заказ.
Описание: This book outlines planning and implementation of a Good Manufacturing Processes (GMP) analytical program, structured to build an environment and culture that encourages and rewards the sharing of ideas, skills and abilities among department personnel.
Автор: James M. Miller Название: Analytical Chemistry in a GMP Environment: A Practical Guide ISBN: 0471314315 ISBN-13(EAN): 9780471314318 Издательство: Wiley Рейтинг: Цена: 32464.00 р. Наличие на складе: Есть у поставщика Поставка под заказ.
Описание: How to hone your analytical skills and obtain high-quality data in the era of GMP requirements With increased regulatory pressures on the pharmaceutical industry, there is a growing need for capable analysts who can ensure appropriate scientific practices in laboratories and manufacturing sites worldwide.
Автор: Vesper James L Название: Quality And Gmp Auditing: Clear And Simple ISBN: 1574910558 ISBN-13(EAN): 9781574910551 Издательство: Taylor&Francis Рейтинг: Цена: 29093.00 р. Наличие на складе: Есть у поставщика Поставка под заказ.
Описание: More than just a checklist of audit questions, this guidebook contains proven methods and techniques for performing effective audits. Completely covering the four key competencies essential for successful GMP audits, the book explores the rationale behind using audits as a quality tool and explains the audit cycle broken into five distinct phases. To focus the power of auditing on a particular situation, several different types of audits are presented, as are more than a dozen audit approaches with general questions to answer and specific items to examine. These tools help readers prepare checklists and standards so audits become more effective, consistent, and standardized.
Автор: Thomas Catalano Название: Essential Elements for a GMP Analytical Chemistry Department ISBN: 1489996745 ISBN-13(EAN): 9781489996749 Издательство: Springer Рейтинг: Цена: 19376.00 р. Наличие на складе: Есть у поставщика Поставка под заказ.
Описание: This book outlines planning and implementation of a Good Manufacturing Processes (GMP) analytical program, structured to build an environment and culture that encourages and rewards the sharing of ideas, skills and abilities among department personnel.
Автор: Bhatt, Vinay Название: GMP Compliance, Productivity, and Quality ISBN: 1574910779 ISBN-13(EAN): 9781574910773 Издательство: Taylor&Francis Рейтинг: Цена: 68904.00 р. Наличие на складе: Есть у поставщика Поставка под заказ.
Название: Good Manufacturing Practices Pharma ISBN: 1498732062 ISBN-13(EAN): 9781498732062 Издательство: Taylor&Francis Рейтинг: Цена: 28327.00 р. Наличие на складе: Есть у поставщика Поставка под заказ.
Описание:
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
Essential information for architects, designers, engineers, equipment suppliers, and other professionals who are working in or entering the biopharmaceutical manufacturing field
Biomanufacturing facilities that are designed and built today are radically different than in the past. The vital information and knowledge needed to design and construct these increasingly sophisticated biopharmaceutical manufacturing facilities is difficult to find in published literature--and it's rarely taught in architecture or design schools. This is the first book for architects and designers that fills this void. Process Architecture in Biomanufacturing Facility Design provides information on design principles of biopharmaceutical manufacturing facilities that support emerging innovative processes and technologies, use state-of-the-art equipment, are energy efficient and sustainable, and meet regulatory requirements.
Relying on their many years of hands-on design and operations experience, the authors emphasize concepts and practical approaches toward design, construction, and operation of biomanufacturing facilities, including product-process-facility relationships, closed systems and single use equipment, aseptic manufacturing considerations, design of biocontainment facility and process based laboratory, and sustainability considerations, as well as an outlook on the facility of the future.
Provides guidelines for meeting licensing and regulatory requirements for biomanufacturing facilities in the U.S.A and WHO--especially in emerging global markets in India, China, Latin America, and the Asia/Pacific regions
Focuses on innovative design and equipment, to speed construction and time to market, increase energy efficiency, and reduce footprint, construction and operational costs, as well as the financial risks associated with construction of a new facility prior to the approval of the manufactured products by regulatory agencies
Includes many diagrams that clarify the design approach
Process Architecture in Biomanufacturing Facility Design is an ideal text for professionals involved in the design of facilities for manufacturing of biopharmaceuticals and vaccines, biotechnology, and life-science industry, including architects and designers of industrial facilities, construction, equipment vendors, and mechanical engineers. It is also recommended for university instructors, advanced undergraduates, and graduate students in architecture, industrial engineering, mechanical engineering, industrial design, and industrial interior design.
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