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.

Information

Publisher

Year

Print ISBN

eBook ISBN

Edition

Topic

Medicine

Subtopic

Pharmacology

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

About this book

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Table of contents