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Validating Pharmaceutical Systems: Good Computer Practice In Life Science Manufacturing - Hardcover

 
9780849323249: Validating Pharmaceutical Systems: Good Computer Practice In Life Science Manufacturing
Hardcover
ISBN 10: 084932324X ISBN 13: 9780849323249
Verlag: CRC Press Inc, 2005

Inhaltsangabe

All too often, the words "computer validation" strike terror into the hearts of those new to the process and may even cause those familiar with it to tremble. Validating Pharmaceutical Systems: Good Computer Practice in Life Science Manufacturing delineates GCP, GLP, and GMP regulatory requirements and provides guidance from seasoned practitioners on how to fulfill them. John Andrews and his team tackle the perceived complexities surrounding the validation of a wide variety of automated systems.

Sprinkled with case studies and real-life examples, the book offers a step-by-step review of topics such as planning, design, auditing, risk management, and specification. The in-depth, by example coverage demystifies the challenges of manufacturing execution systems(MES), laboratory information management systems(LIMS), and network qualification.

The first section examines the different levels of automated systems used throughout the drug development, manufacture, and delivery lifecycle, using the GAMP 4 lifecycle approach to their validation. The second section uncovers some real-life applications of GAMP 4 to different areas of the regulations such as GLP, GCP, GMP, and GDP.

The book explores some of the latest thinking on computer validation and reflects changes that have occurred in the industry since the early days of validation. The contributors are a deliberate blend of those who have faced the problems of the 1990s and the Y2K controversies and those who have more recently arrived on the scene and made an impact on the perception of validation of automated systems across the field of GxP. They do more than show you how to do the right thing; they show you how to do the right thing in compliance with regulations.

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Über die Autorin bzw. den Autor

John Andrews

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Verlag
CRC Press Inc
Erscheinungsdatum
2005
Sprache
Englisch
ISBN 10 
084932324X
ISBN 13 
9780849323249
Einband
Gebundene Ausgabe
Anzahl der Seiten
549
Herausgeber
Andrews John
Kontakt zum Hersteller
Nicht verfügbar
Verantwortliche Person
Buchpark GmbH
gpsr@buchpark.de

Krügerweg 1
Trebbin
Brandenburg
14959
Deutschland