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Pharmaceutical Water: System Design, Operation, and Validation, William V. Collentro



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Цена: 20625р.
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Автор: William V. Collentro
Название:  Pharmaceutical Water: System Design, Operation, and Validation
ISBN: 9781420077827
Издательство: Taylor&Francis
Классификация:
ISBN-10: 1420077821
Обложка/Формат: Hardback
Страницы: 750
Вес: 1.07 кг.
Дата издания: 2008.10.01
Серия: Pharmaceutical science
Язык: English
Издание: 2 rev ed
Иллюстрации: 146 black & white illustrations
Размер: 262 x 186 x 26
Читательская аудитория: Professional & vocational
Подзаголовок: System design, operation, and validation
Рейтинг:
Поставляется из: Англии



Automation and Validation of Information in Pharmaceutical Processing

Автор: Despautz
Название: Automation and Validation of Information in Pharmaceutical Processing
ISBN: 0824701194 ISBN-13(EAN): 9780824701192
Издательство: Taylor&Francis
Рейтинг:
Цена: 11339 р.
Наличие на складе: Поставка под заказ.

Описание: This thoroughly authoritative work furnishes organizational, technological, validation, project management, and business perspectives on pharmaceutical information automation from industry and system automation professionals-demonstrating how to fulfill computer system validation requirements for hardware, applications, networks, data center operations, and complex software management practices in pharmaceutical manufacturing.
Explains how the Food and Drug Administration's latest Good Manufacturing Process guidelines supporting electronic identification and electronic signatures for batch record registration together with computer system technologies will influence pharmaceutical production automation!
Designed to provide quick and easy access to a whole range of system development topics, Automation and Validation of Information in Pharmaceutical Processing

  • defines a complete life-cycle methodology that integrates equipment, people, and information
  • presents concepts, guidelines, test plans, example forms, and application details for previously unavailable computer system validation of complex automated information systems
  • introduces, for the first time in depth, PQ testing of integrated manufacturing execution (MES) and manufacturing resource planning (MRP) applications
  • describes how human resource programs maximize productivity gains for automation initiatives
  • discusses approaches to automating batch operations with process control systems using industry examples and applicable computer technology concepts
  • provides an outline for IQ, OQ, and PQ test plans for process control systems, including forms for use in testing instrumentation and distributed control system installation and operations
  • employs a business analysis standpoint on life-cycle planning to justify new automation projects, including multiyeardrug manufacturing plans
  • documents the successful app
  • EU Annex 11 Guide to Computer Validation Compliance for the Worldwide Health Agency GMP

    Автор: Lopez
    Название: EU Annex 11 Guide to Computer Validation Compliance for the Worldwide Health Agency GMP
    ISBN: 1482243628 ISBN-13(EAN): 9781482243628
    Издательство: Taylor&Francis
    Рейтинг:
    Цена: 24750 р.
    Наличие на складе: Невозможна поставка.

    Описание: Good Manufacturing Practice (GMP) ensures medicinal products are produced consistently and controlled to the quality standards appropriate for their intended use and as required by product specifications or marketing authorization. Annex 11 details the European Medicines Agency (EMA) GMP requirements for computer systems.The purpose of Annex 11 is to provide the EMA healthcare industry with consistent criteria for effective implementation, control, and use of computer systems. EU Annex 11 Guide to Computer Validation Compliance for the Worldwide Health Agency GMP supplies practical information to facilitate compliance with computer system GMP requirements, while highlighting and integrating the Annex 11 guidelines into the computer compliance program.The ideas presented in this book are based on the author’s 25 years of experience with computer validation in the healthcare industry with various computer systems development, maintenance, and quality functions. The book details a practical approach to increase efficiency and to ensure that software development and maintenance are achieved correctly.Examining the implementation of the computer systems validation entirely based on EU Annex 11, the book includes examples from laboratory, clinical, and manufacturing computer systems. It also discusses electronic record integrity associated with stored information.

    Method Validation in Pharmaceutical Analysis: A Guide to Best Practice

    Автор: Joachim Ermer
    Название: Method Validation in Pharmaceutical Analysis: A Guide to Best Practice
    ISBN: 3527312552 ISBN-13(EAN): 9783527312559
    Издательство: Wiley
    Рейтинг:
    Цена: 19938 р.
    Наличие на складе: Поставка под заказ.

    Описание: Adopting a practical approach, the authors provide a detailed interpretation of the existing regulations (GMP, ICH), while also discussing the appropriate calculations, parameters and tests. The book thus allows readers to validate the analysis of pharmaceutical compounds while complying with both the regulations as well as the industry demands for robustness and cost effectiveness.
    Following an introduction to the basic parameters and tests in pharmaceutical validation, including specificity, linearity, range, precision, accuracy, detection and quantitation limits, the text focuses on a life-cycle approach to validation and the integration of validation into the whole analytical quality assurance system. The whole is rounded off with a look at future trends.
    With its first-hand knowledge of the industry as well as regulating bodies, this is an invaluable reference for analytical chemists, the pharmaceutical industry, pharmaceutists, QA officers, and public authorities.

    Integrated Design and Operation of Water Treatment Facilities, 2nd Edition

    Автор: Susumu Kawamura
    Название: Integrated Design and Operation of Water Treatment Facilities, 2nd Edition
    ISBN: 0471350931 ISBN-13(EAN): 9780471350934
    Издательство: Wiley
    Рейтинг:
    Цена: 23093 р.
    Наличие на складе: Поставка под заказ.

    Описание: Water treatment facilities collect, filter, and then pump water to all municipalities. As technological breakthroughs, legislation, or even population shifts occur, these facilities need to be updated or rebuilt, or new facilities need to be designed where none existed before.

    Pharmaceutical Water: System Design, Operation, And Validation

    Автор: Collentro William V
    Название: Pharmaceutical Water: System Design, Operation, And Validation
    ISBN: 1574910272 ISBN-13(EAN): 9781574910278
    Издательство: Informa
    Цена: 20543 р.
    Наличие на складе: Нет в наличии.

    Описание: From chemical and biological purity requirements, to system design and its impact on water purity, to the requirements and restrictions imposed by the regulators, this book comprehensively covers the unique water requirements of the pharmaceutical and biotechnology industries. Beginning with a brief overview of the theory and application of the technology, William Collentro clarifies the seemingly overwhelming engineering aspects as he discusses design considerations, operation, maintenance, validation, and regulatory-related topics bases upon personal experience with more than 400 pharmaceutical and related water purification systems. His extensive field experience and the numerous case studies recounted in this book ensure that all relevant aspects of pharmaceutical water technology are thoroughly explained in a clear, concise style.Features

    Pharmaceutical And Medical Device Validation By Experimental Design

    Автор: Torbeck Lynn D
    Название: Pharmaceutical And Medical Device Validation By Experimental Design
    ISBN: 1420055690 ISBN-13(EAN): 9781420055696
    Издательство: Informa
    Рейтинг:
    Цена: 17119 р.
    Наличие на складе: Нет в наличии.

    Описание: This title demonstrates how designed experiments are the most scientific, efficient, and cost effective method of data collection for validation in a laboratory setting. Intended as a learn-by-example guide, Pharmaceutical Validation by Experimental Design demonstrates why designed experiments are the most logical and rational approach to use, using realistic case studies, illustrations, and where appropriate, step-by-step protocols and procedures.

    Название: Validation Of Pharmaceutical Water
    ISBN: 1574448951 ISBN-13(EAN): 9781574448955
    Издательство: Taylor&Francis
    Цена: 44481 р.
    Наличие на складе: Поставка под заказ.

    Pharmaceutical Equipment Validation: The Ultimate Qualification Guidebook: The Ultimate Qualification Handbook

    Автор: Cloud Phil
    Название: Pharmaceutical Equipment Validation: The Ultimate Qualification Guidebook: The Ultimate Qualification Handbook
    ISBN: 1574910795 ISBN-13(EAN): 9781574910797
    Издательство: Informa
    Рейтинг:
    Цена: 24651 р.
    Наличие на складе: Невозможна поставка.

    Описание: Comprehensively covering equipment qualification and process validation for pharmaceutical process equipment, this text shows readers how to demonstrate compliance, what data to use, and how to produce the appropriate documentation. The author demonstrates how to prepare, test, and complete equipment qualification protocols. He also explains how to perform qualification testing and whether to test the equipment for a worst-case scenario. The thirty-eight completed protocol templates cover specific equipment types, provide instant answers to most protocol writing and testing questions, show how to qualify each piece of equipment, and provide a check for readers' own protocols.

    Название: Validation Of Pharmaceutical Proces
    ISBN: 1574448943 ISBN-13(EAN): 9781574448948
    Издательство: Taylor&Francis
    Цена: 44481 р.
    Наличие на складе: Поставка под заказ.

    Validation Of Pharmaceutical Processes

    Автор: Agalloco James P
    Название: Validation Of Pharmaceutical Processes
    ISBN: 0849370558 ISBN-13(EAN): 9780849370557
    Издательство: Informa
    Рейтинг:
    Цена: 24651 р.
    Наличие на складе: Нет в наличии.

    Описание: Completely revised and updated to reflect the significant advances in pharmaceutical production and regulatory expectations, this third edition of Validation of Pharmaceutical Processes examines and blueprints every step of the validation process needed to remain compliant and competitive. The many chapters added to the prior compilation examine validation and six sigma system design; the preparation of aseptic and non-aseptic pharmaceutical products; active pharmaceutical ingredient and biotechnology processes, computerized systems; qualification and cleaning of equipment; analytical methods, calibration and certification. As the industry's leading source for validation of sterile pharmaceutical processes for more than 10 years, this greatly expanded is a comprehensive analysis of all of the fundamental elements of this arena with practical solutions for every pharmaceutical and bio-pharmaceutical production process.

    Power System Engineering: Planning, Design, and Operation of Power Systems and Equipment

    Автор: Schlabbach
    Название: Power System Engineering: Planning, Design, and Operation of Power Systems and Equipment
    ISBN: 3527407596 ISBN-13(EAN): 9783527407590
    Издательство: Wiley
    Рейтинг:
    Цена: 19250 р.
    Наличие на складе: Поставка под заказ.

    Описание: Describing how electrical power systems are planned and designed, this monograph illustrates the required structures of systems, substations and equipment using latest computer methods. It discusses the advantages and disadvantages of the different arrangements within switchyards and of the topologies of the power systems.

    Method Validation in Pharmaceutical Analysis: A Guide to Best Practice

    Название: Method Validation in Pharmaceutical Analysis: A Guide to Best Practice
    ISBN: 3527335633 ISBN-13(EAN): 9783527335633
    Издательство: Wiley
    Рейтинг:
    Цена: 20068 р.
    Наличие на складе: Поставка под заказ.

    Описание: This second edition of a global best–seller has been completely redesigned and extensively rewritten to take into account the new Quality by Design (QbD) concept in pharmaceutical manufacturing. As in the first edition, the analytical requirements during the entire product lifecycle are covered, but now a new section is included on continued performance monitoring and the transfer of analytical procedures. Two case studies from the pharmaceutical industry illustrate the concepts and guidelines presented, and the standards and regulations from the US (FDA), European (EMA) and global (ICH) regulatory authorities are considered throughout. The undisputed gold standard in the field.


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