Validating Pharmaceutical Systems: Good Computer Practice in Life Science Manufacturing
By addebook • Jul 15th, 2008 • Category: Pharmacy
Validating Pharmaceutical Systems: Good Computer Practice in Life Science Manufacturing
Validating Pharmaceutical Systems: Good Computer Practice in Life Science Manufacturing
By John Andrews
Publisher: Informa Healthcare
Number Of Pages: 576
Publication Date: 2005-08-03
ISBN-10 / ASIN: 084932324X
ISBN-13 / EAN: 9780849323249
Binding: Hardcover
This highly readable text offers a pragmatic approach to the validation of automated/computerized systems, an essential core task when establishing and maintaining compliance with global regulatory authorities, such as the FDA and the MHRA. 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.
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