Principles of Parenteral Solution Validation: A Practical Lifecycle Approach

Principles of Parenteral Solution Validation: A Practical Lifecycle Approach covers all aspects of the activities required in the development and process validation of a parenteral product. By using a lifecycle approach, this book discusses the latest technology, compliance developments, regulatory considerations and recent 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 in order to address and offer solutions to the daily challenges facing practitioners in this area.

Discusses international and domestic regulatory considerations in every sectionFeatures boxes that contain points of interest for each segment of the audience so readers can quickly find their interests and needs Contains important topics, including risk management, the preparation and execution of properly design studies, scale-up and technology transfer activities, problem-solving, and more

1. Aseptic Process Validation, Part 1: Design and Planning 2. Aseptic Process Validation Design, Part 2: Aseptic Process Simulation Design 3. Quality Risk Management of Parenteral Process Validation, Part 1: Fundamentals 4. Equipment Cleaning Process 5. Quality Risk Management of Parenteral Process Validation, Part 2: A Risk-Based Quality Management System 6. Use of Statistics in Process Validation 7. Process Validation Stage 1: Parenteral Process Design 8. Process Validation Stage 2: Parenteral Process Performance Qualification 9. Process Validation Stage 3: Continued Process Verification 10. Preuse/Poststerilization Integrity Testing of Sterilizing Grade Filter 11. Environmental Monitoring 12. Isolators 13. Post Aseptic Fill Sterilization and Lethal Treatment