Facility Validation: Theory, Practice, and Tools

✍ Scribed by Graham C. Wrigley

Publisher: Informa Healthcare
Year: 2004
Tongue: English
Leaves: 142
Edition: 1
Category: Library

No coin nor oath required. For personal study only.

✦ Synopsis

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.

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