Validating Pharmaceutical Systems

Good Computer Practice in Life Science Manufacturing
Herausgeber: Andrews, John

• Broschiertes Buch

Produktbeschreibung

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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Produktdetails

• Verlag: CRC Press
• Seitenzahl: 572
• Erscheinungstermin: 7. Oktober 2019
• Englisch
• Abmessung: 234mm x 156mm x 31mm
• Gewicht: 857g
• ISBN-13: 9780367392383
• ISBN-10: 0367392380
• Artikelnr.: 58055254

Autorenporträt

John Andrews

Inhaltsangabe

Foreword. Editor's Introduction. Considerations for Computerized System
Validation in the 21st Century Life Sciences Sector. An Inspector's
Viewpoint. State of the Art Risk Assessment and Management. Validation
Planning and Reporting. Audit Preparation for Suppliers: A Question and
Answer Approach. Developing Good Specifications. Traceability of
Requirements Throughout the Lifecycle. Good Documentation in Practice. Good
Testing Practice: Part 1. Enterprise Resource Planning Services - Aligning
Business and Validation Requirements. Calibration in Practice. Validating
Legacy Systems. Technology Transfer Keys. Qualifying SCADA Systems in
Practice Acquisition. The Application of GAMP4 Guidelines to Computer
Systems Found in GLP Regulated. The Validation of a LIMS System - A Case
Study. Compliance and Validation in Central and
Eastern Europe (CEE). Distribution Management Validation in Practice.