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.
- Discusses international and domestic regulatory considerations in every section
- Features callout 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 designed studies, scale-up and technology transfer activities, problem-solving, and more
Sprache
Verlagsort
Verlagsgruppe
Elsevier Science & Techn.
ISBN-13
978-0-12-809446-4 (9780128094464)
Schweitzer Klassifikation
1. Aseptic Process Validation, Part 1: Design and Planning2. Aseptic Process Validation Design, Part 2: Aseptic Process Simulation Design3. Quality Risk Management of Parenteral Process Validation, Part 1: Fundamentals4. Equipment Cleaning Process5. Quality Risk Management of Parenteral Process Validation, Part 2: A Risk-Based Quality Management System6. Use of Statistics in Process Validation7. Process Validation Stage 1: Parenteral Process Design8. Process Validation Stage 2: Parenteral Process Performance Qualification9. Process Validation Stage 3: Continued Process Verification10. Preuse/Poststerilization Integrity Testing of Sterilizing Grade Filter11. Environmental Monitoring12. Isolators13. Post Aseptic Fill Sterilization and Lethal Treatment
