Pharmaceutical engineering change control

Pharmaceutical engineering change control

by Turner, Simon G.

Type Book
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Written especially for the pharmaceutical industry professional, this book addresses each part of the life-cycle of engineering change control. It covers issues in the EU and US and describes the operational requirements and responsibilities that ensure change controls are effectively applied and recorded. Providing guidance on how to demonstrate that a change control system is working, the book includes chapters on computer validation, customization of the change process to each project's need…

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Title Statements

  • Full title :Pharmaceutical engineering change control / editor, Simon G. Turner.

Summary

Written especially for the pharmaceutical industry professional, this book addresses each part of the life-cycle of engineering change control. It covers issues in the EU and US and describes the operational requirements and responsibilities that ensure change controls are effectively applied and recorded. Providing guidance on how to demonstrate that a change control system is working, the book includes chapters on computer validation, customization of the change process to each project's needs, and case histories and anecdotes illustrate key points and provide a basis for change control trai.

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Edition Statements

  • Publication Date:©2004.
  • Edition:2nd ed

Publication Statements

  • Publisher(s):Interpharm/CRC Press
  • Place of Publication:Boca Raton, FL
  • Language:eng
  • Publication Date:©2004.

The Physical Object

  • Description:1 online resource (177 pages) : : illustrations

Edition Identifiers

  • ISBN:0203508823, 9780203508824
  • oclc:ocm56573351
  • LC Classification:RS192
  • Dewey Decimal:615/.19/00685

Table of Contents

Change Is Inevitable -- Why? -- Regulation of Change Control for Drugs and Biologics -- U.S. -- A Regulatory View -- EU -- The Operational Phase -- The Change Control System -- Change Control and Computer Systems -- Case Histories and Anecdotes -- Projects -- List of Abbreviations -- Glossary -- Index.

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Subjects

Drug Approval Drug Industry -- organization & adminis… Electronic book Electronic books MEDICAL -- Drug Guides MEDICAL -- Nursing MEDICAL -- Pharmacology MEDICAL -- Pharmacy Pharmaceutical technology -- Quality co… Production -- Gestion Production management Qualité -- Contrôle Quality control Risk Management -- methods Techniques pharmaceutiques -- Qualité Technology, Pharmaceutical -- standards

Writers

Turner, Simon G.

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