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Automation and Validation of Information in Pharmaceutical Processing.

Automation and Validation of Information in Pharmaceutical Processing.

・ISBN 978-0-8247-0119-2 hard GB£ 210.00

￥66,528.- (税込) ※（※）価格はご注文時の参考価格となります。
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電子版あり 大学・学術機関向け電子ブック（eBook）ISBN 9780429074981

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著者・編者deSpautz, Joseph F.,
シリーズ (Drugs and the Pharmaceutical Sciences)
出版社 (CRC Press Inc, US)
出版年月1998
ページ数464 pp.
言語ENG
ニュース番号＜A00-35059＞

解説

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 multiyear drug manufacturing plans
  • documents the successful application of life-cycle methodologies to supply chain functions
  • and much more!
    Together with references, tables, and drawings, Automation and Validation of Information in Pharmaceutical Processing is an essential, hands-on resource for pharmaceutical scientists, manufacturers, and engineers; drug quality assurance and regulatory personnel; project and program manufacturers; information system professionals and software developers and analysts; information technology practitioners; and graduate-level and continuing-education students in these disciplines.