Igor Gorsky,
Harold S. Baseman
Principles of Parenteral Solution Validation
A Practical Lifecycle Approach
Paperback Engels 2019 9780128094129Levertijd ongeveer 9 werkdagen
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Samenvatting
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.
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Inhoudsopgave
<p>1. Aseptic Process Validation, Part 1: Design and Planning<br>2. Aseptic Process Validation Design, Part 2: Aseptic Process Simulation Design<br>3. Quality Risk Management of Parenteral Process Validation, Part 1: Fundamentals<br>4. Equipment Cleaning Process<br>5. Quality Risk Management of Parenteral Process Validation, Part 2: A Risk-Based Quality Management System<br>6. Use of Statistics in Process Validation<br>7. Process Validation Stage 1: Parenteral Process Design<br>8. Process Validation Stage 2: Parenteral Process Performance Qualification<br>9. Process Validation Stage 3: Continued Process Verification<br>10. Preuse/Poststerilization Integrity Testing of Sterilizing Grade Filter<br>11. Environmental Monitoring<br>12. Isolators<br>13. Post Aseptic Fill Sterilization and Lethal Treatment</p>
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