Front Cover; Preface; Author; Introduction; Contents; 1. The Regulatory Requirements for Validation in the Pharmaceutical Industry; 2. The Fundamentals and Essentials of Validation; 3. The Practice of Facility Validation; 4. Twenty Tools Recommended for Facility Validation; 5. Good Validation Practices; 6. Conclusions and Future Directions; 7. Glossary of Definitions and Terms Associated with Validation; Index
Summary
Looking at validation issues specific to the start-up of a new or upgraded manufacturing facility, this book provides definitions of policies, guidelines, and regulations concerning Good Manufacturing Practices in pharmaceutical industries worldwide