Validating Pharmaceutical Systems: Good Computer Practice in Life Science Manufacturing

Validating Pharmaceutical Systems: Good Computer Practice in Life Science Manufacturing

by John Andrews
     
 

This highly readable text offers a pragmatic approach to the validation of automated/computerized systems, an essential step for maintaining compliance with global regulatory authorities, such as the FDA. It examines the different levels of automated systems used throughout the drug development, manufacture, and delivery life cycle, using the GAMP-4 life cycle

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Overview

This highly readable text offers a pragmatic approach to the validation of automated/computerized systems, an essential step for maintaining compliance with global regulatory authorities, such as the FDA. It examines the different levels of automated systems used throughout the drug development, manufacture, and delivery life cycle, using the GAMP-4 life cycle approach to their validation. Rich with case studies and real-life examples, it also supplies the reader with true applications of GAMP 4 to different areas of regulations, such as good laboratory practice, good clinical practice, good manufacturing practice, and good data practice.

Product Details

ISBN-13:
9780849323249
Publisher:
Taylor & Francis
Publication date:
08/03/2005
Pages:
572
Product dimensions:
6.20(w) x 9.30(h) x 1.50(d)

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