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Pharmaceutical Engineering Change Control

By: Simon G. Turner (Edited by)

Manufacture on Demand

Ksh 45,600.00

Format: Hardback or Cased Book

ISBN-10: 0849320615

ISBN-13: 9780849320613

Edition Number: 2

Publisher: Taylor & Francis Inc

Imprint: CRC Press Inc

Country of Manufacture: GB

Country of Publication: GB

Publication Date: Dec 15th, 2003

Publication Status: Active

Product extent: 200 Pages

Weight: 399.00 grams

Product Classification / Subject(s): Pharmaceutical technology

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Written especially for the pharmaceutical industry professional, this volume 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.
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 training. It gives readers a toolbox for ensuring that adequate controls are implemented.

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