Facility Validation: Theory, Practice, and Tools - Hardcover

Wrigley, Graham C.

Hardcover

ISBN 10: 0849323401 ISBN 13: 9780849323409

Publisher: CRC Press, 2004

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 this title

About the Author

Graham C. Wrigley

Edition details

• Publisher: CRC Press
• Publication date: 2004
• Language: English
• ISBN 10: 0849323401
• ISBN 13: 9780849323409
• Binding: Hardcover
• Edition number: 1
• Number of pages: 160