Facility Validation: Theory, Practice, and Tools

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Facility Validation: Theory, Practice,...

Facility Validation: Theory, Practice, and Tools

Name: Facility Validation: Theory, Practice, and Tools
ISBN: 9780849323409

Graham C. Wrigley

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Focusing on validation issues specific to the start-up of a new or upgraded manufacturing facility, this book provides definitions of the policies, guidelines, and regulations relating to Good Manufacturing Practices (GMPs) in pharmaceutical industries worldwide. The author discusses the validation concepts, definitions, and terminology associated with GMPs and details the philosophy and key principles of validation. He demonstrates how to set up an infrastructure for implementing a validation program. Included in the book are practical examples of validation documents and SOPs, a comprehensive glossary of validation terminology, and coverage of best practices for evaluating validation programs.

Categorias:

Medicine

Ano:

2004

Edição:

Editora:

Informa Healthcare

Idioma:

english

Páginas:

160

ISBN 10: