Pharmaceutical Engineering Change Control
Book Details
Format
Hardback or Cased Book
ISBN-10
0849320615
ISBN-13
9780849320613
Publisher
Taylor & Francis Inc
Imprint
CRC Press Inc
Country of Manufacture
GB
Country of Publication
GB
Publication Date
Dec 15th, 2003
Print length
200 Pages
Weight
399 grams
Product Classification:
Pharmaceutical technology
Ksh 34,200.00
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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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