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Principles of Parenteral Solution Validation: A Practical Lifecycle Approach covers all aspects involved in the development and process validation of a parenteral product.… Read more
LIMITED OFFER
Immediately download your ebook while waiting for your print delivery. No promo code is needed.
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.
Pharmaceutical and associated industry professionals involved in process development and qualification of parenteral products, including R&D personnel involved in manufacturing, technology transfer and quality assurance, as well as process engineers and regulatory officials
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
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