Facility Validation —— Theory, Practice, and Tools

----- 设施验证

ISBN: 9780849323409 出版年：2004 页码：152 Wrigley, Graham C CRC Press

Foreword 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