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    3. Facility Validation: Theory, Practice, and Tools (repost)

    Facility Validation: Theory, Practice, and Tools (repost)

    Posted By: rolexmaya
    Date: 13 Aug 2010 07:53:29
    Facility Validation: Theory, Practice, and Tools (repost)

    Facility Validation: Theory, Practice, and Tools
    Informa Healthcare; 1 edition | March 29, 2004 | ISBN-10: 0849323401 | 160 pages | PDF | 1.6 Mb

    Focusing on validation issues specific to the start-up of a new or upgraded manufacturing facility, this book provide 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 best practices for evaluating validation programs.

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