eBook - PDF
Pharmaceutical Process Validation
An International
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- 776 pages
- English
- PDF
- Available on iOS & Android
eBook - PDF
Pharmaceutical Process Validation
An International
Book details
Table of contents
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About This Book
The third edition of this text contains additional chapters which cover troubleshooting procedures, validation in contract manufacturing and current harmonization trends.
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Yes, you can access Pharmaceutical Process Validation by Robert A. Nash, Alfred H. Wachter, Robert A. Nash, Alfred H. Wachter in PDF and/or ePUB format, as well as other popular books in Medicine & Pharmacology. We have over one million books available in our catalogue for you to explore.
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Table of contents
- Front Cover
- Preface
- Contents
- Contributors
- Introduction
- Chapter 1. Regulatory Basis for Process Validation
- Chapter 2. Prospective Process Validation
- Chapter 3. Retrospective Validation
- Chapter 4. Sterilization Validation
- Chapter 5. Validation of Solid Dosage Forms
- Chapter 6. Validation for Medical Devices
- Chapter 7. Validation of Biotechnology Processes
- Chapter 8. Transdermal Process Validation
- Chapter 9. Validation of Lyophilization
- Chapter 10. Validation of Inhalation Aerosols
- Chapter 11. Process Validation of Pharmaceutical Ingredients
- Chapter 12. Qualification of Water and Air Handling Systems
- Chapter 13. Equipment and Facility Qualification
- Chapter 14. Validation and Verification of Cleaning Processes
- Chapter 15. Validation of Analytical Methods and Processes
- Chapter 16. Computer System Validation: Controlling the Manufacturing Process
- Chapter 17. Integrated Packaging Validation
- Chapter 18. Analysis of Retrospective Production Data Using Quality Control Charts
- Chapter 19. Statistical Methods for Uniformity and Dissolution Testing
- Chapter 20. Change Control and SUPAC
- Chapter 21. Process Validation and Quality Assurance
- Chapter 22. Validation in Contract Manufacturing
- Chapter 23. Terminology of Nonaseptic Process Validation
- Chapter 24. Harmonization, GMPs, and Validation
- Index
- Back Cover