160 Pages
22 B/W Illustrations
by
CRC Press
160 Pages
by
CRC Press
Also available as eBook on:
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... Read more
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
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
