Facility Validation : Theory, Practice, and Tools

Graham C. Wrigley

ISBN 10: 0849323401 / ISBN 13: 9780849323409

Published by Taylor & Francis Inc Mär 2004, 2004

About this Item

Neuware - 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.

Seller Inventory # 9780849323409

Bibliographic Details

• Title: Facility Validation : Theory, Practice, and Tools
• Publisher: Taylor & Francis Inc Mär 2004
• Publication Date: 2004
• Language: English
• ISBN 10: 0849323401
• ISBN 13: 9780849323409
• Binding: Buch
• Condition: Neu
• Dimensions: 234W x 156H x 0D millimeters 234 millimeters width by 156 millimeters height by 0 millimeters depth
• Weight: 368 grams

About this title

Synopsis

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

About the Author

Graham C. Wrigley