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.
Introduction
THE REGULATORY REQUIREMENTS FOR VALIDATION IN THE PHARMACEUTICAL INDUSTRY
The Regulatory Requirements of Good Manufacturing Practices (GMP's)
The Relationship between Validation and the GMP's
The Impact of Changing Regulations on the Scope and Extent of Validation
The Future for the GMP's
THE FUNDAMENTALS AND ESSENTIALS OF VALIDATION
Validation Concepts, Definitions and Terminology
The Philosophy and Key Principles of Validation
Organizing and Planning for Validation
The Essential Validation Disciplines
THE PRACTICE OF FACILITY VALIDATION
A Typical Life Cycle Approach for the Qualification and Validation of a Pharmaceutical Manufacturing Facility
TWENTY TOOLS RECOMMENDED FOR FACILITY VALIDATION
Common Problems associated with Facility Validation
Good Validation Practices
GOOD VALIDATION PRACTICES
The Benefits of Following Good Validation Practices in Facility Validation Projects
The Consequences of Not Following these Good Validation Practices
CONCLUSIONS AND FUTURE DIRECTIONS
Biography
Graham C. Wrigley
