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Validating Pharmaceutical Systems

Validating Pharmaceutical Systems

John Andrews

119,05 €
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Editorial:
Taylor & Francis Ltd
Año de edición:
2019
Materia
Química
ISBN:
9780367392383
119,05 €
IVA incluido
Disponible

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Sobre IBD

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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