Author: Graham C. Wrigley
Edition: 1
Publisher: CRC Press
Binding: Hardcover
ISBN: 0849323401
Facility Validation: Theory, Practice, and Tools
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. Medical books Facility Validation. 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 Medical books Facility Validation Theory, Practice, and Tools, 9780849323409. Facility Validation Theory, Practice, and Tools, ISBN-13: 9780849323409, ISBN-10: 0849323401
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Facility Validation Theory, Practice, and Tools, ISBN-13: 9780849323409, ISBN-10: 0849323401
Store Search search Title, ISBN and Author Facility Validation: Theory, Practice, and Tools by Graham C. Wrigley, Wrigley C. Wrigley Estimated delivery 3-12 business days Format Hardcover Condition Brand New 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 proces
"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 comprehensi
"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 comprehensi
Medical Book Facility Validation
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.
