chapter 1 The Regulatory Requirements for Validation in the Pharmaceutical Industry -- chapter 2 The Fundamentals and Essentials of Validation -- chapter 3 1A Typical Life-Cycle Approach for the Qualification and Validation of a Pharmaceutical Manufacturing Facility -- chapter 4 Twenty Tools Recommended for Facility Validation -- chapter 5 Good Validation Practices -- chapter 6 Conclusions and Future Directions -- chapter 7 Glossary of Definitions and Terms Associated with Validation.