Principles of Parenteral Solution Validation: A Practical Lifecycle Approach covers all aspects involved in the development and process validation of a parenteral product. By using a lifecycle approach, this book discusses the latest technology, compliance developments, and regulatory considerations and trends, from process design, to divesting. As part of the Expertise in Pharmaceutical Process Technology series edited by Michael Levin, this book incorporates numerous case studies and real-world examples that address timely problems and offer solutions to the daily challenges facing practitioners in this area.
1. Introduction - p. 1 2. Chapter 1. Process Validation: Design and Planning - p. 9 3. Chapter 2. Aseptic Process Validation: Aseptic Process Simulation Design - p. 33 4. Chapter 3. Quality Risk Management of Parenteral Process Validation, Part 1: Fundamentals - p. 61 5. Chapter 4. Equipment Cleaning Process - p. 81 6. Chapter 5. Quality Risk Management of Parenteral Process Validation, Part 2: A Risk-Based Quality Management System - p. 97 7. Chapter 6. Use of Statistics in Process Validation - p. 115 8. Chapter 7. Process Validation Stage 1: Parenteral Process Design - p. 137 9. Chapter 8. Process Validation Stage 2: Parenteral Process Performance Qualification - p. 177 10. Chapter 9. Process Validation Stage 3: Continued Process Verification - p. 209 11. Chapter 10. Preuse/Poststerilization Integrity Testing of Sterilizing Grade Filter - p. 233 12. Chapter 11. Environmental Monitoring - p. 243 13. Chapter 12. Isolators - p. 255 14. Chapter 13. Post Aseptic Fill Sterilization and Lethal Treatment - p. 261 15. Conclusion - p. 269 16. Index - p. 273
Principles of Parenteral Solution Validation: A Practical Lifecycle Approach covers all aspects involved in the development and process validation of a parenteral product. By using a lifecycle approach, this book discusses the latest technology, compliance developments, and regulatory considerations and trends, from process design, to divesting. As part of the Expertise in Pharmaceutical Process Technology series edited by Michael Levin, this book incorporates numerous case studies and real-world examples that address timely problems and offer solutions to the daily challenges facing practitioners in this area.
1. Introduction - p. 1 2. Chapter 1. Process Validation: Design and Planning - p. 9 3. Chapter 2. Aseptic Process Validation: Aseptic Process Simulation Design - p. 33 4. Chapter 3. Quality Risk Management of Parenteral Process Validation, Part 1: Fundamentals - p. 61 5. Chapter 4. Equipment Cleaning Process - p. 81 6. Chapter 5. Quality Risk Management of Parenteral Process Validation, Part 2: A Risk-Based Quality Management System - p. 97 7. Chapter 6. Use of Statistics in Process Validation - p. 115 8. Chapter 7. Process Validation Stage 1: Parenteral Process Design - p. 137 9. Chapter 8. Process Validation Stage 2: Parenteral Process Performance Qualification - p. 177 10. Chapter 9. Process Validation Stage 3: Continued Process Verification - p. 209 11. Chapter 10. Preuse/Poststerilization Integrity Testing of Sterilizing Grade Filter - p. 233 12. Chapter 11. Environmental Monitoring - p. 243 13. Chapter 12. Isolators - p. 255 14. Chapter 13. Post Aseptic Fill Sterilization and Lethal Treatment - p. 261 15. Conclusion - p. 269 16. Index - p. 273
