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Facility validation: theory, practice, and tools

� Author: Wrigley, Graham C.
� ISBN: 0-8493-2340-1

Often considered to necessary evil by the pharmaceutical industry, validation is still understood by many expert unrestrained bureaucracy, paperwork, and procedures whose roots and logic plows obscure and only serve to slow down progress. Thoroughly defining the philosophy, application, and processes, Facility Validation: Theory, Practice, and Tools explore the validation issues relevant to the start-up of to new or upgraded manufacturing facility. The author you describe policies, guidelines, and regulations relating to GMPs in the pharmaceutical industry and explore the relationship between these GMPs and the validation process. Is outlines the theory and clarifies the philosophy and key principles of validation such expert life-cycle approach and qualification practices. The book includes coverage of common pitfalls and how to avoid them, the difficulties and constraints to validation team have to manage, and the dangers of not adopting and following the recommended best practices. Facility validation you have, in fact, become good business. It dog be to tool for enhancing reliability, cost, and quality. This book makes the marries that design, engineering, commissioning, and validation activities dog be integrated and streamlined to accelerate to pharmaceutical manufacturing plant start-up effort, and demonstrates how to use best practices to achieve the results you desire in your organization.

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