eBook - ePub
Pharmaceutical Process Validation
An International
- 776 pages
- English
- ePUB (mobile friendly)
- Available on iOS & Android
eBook - ePub
Pharmaceutical Process Validation
An International
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 & Chemistry. We have over one million books available in our catalogue for you to explore.
Information
Table of contents
- Cover
- Halftitle Page
- Drugs and the Pharmaceutical Sciences
- Drugs and the Pharmaceutical Sciences
- Title Page
- Copyright Page
- Dedication
- Preface
- Table of Contents
- Contributors
- 1 Regulatory Basis for Process Validation
- 2 Prospective Process Validation
- 3 Retrospective Validation
- 4 Sterilization Validation
- APPENDIX I EXAMPLE PROTOCOL FOR VALIDATION OF THE STERILIZATION PROCESS IN A STEAM AUTOCLAVE
- APPENDIX II MEDIUM CONSIDERATIONS IN PRODUCT SIMULATION TESTS
- 5 Validation of Solid Dosage Forms
- 6 Validation for Medical Devices
- 7 Validation of Biotechnology Processes
- 8 Transdermal Process Validation
- 9 Validation of Lyophilization
- 10 Validation of Inhalation Aerosols
- 11 Process Validation of Pharmaceutical Ingredients
- 12 Qualification of Water and Air Handling Systems
- 13 Equipment and Facility Qualification
- 14 Validation and Verification of Cleaning Processes
- 15 Validation of Analytical Methods and Processes
- 16 Computer System Validation Controlling the Manufacturing Process
- 17 Integrated Packaging Validation
- 18 Analysis of Retrospective Production Data Using Quality Control Charts
- 19 Statistical Methods for Uniformity and Dissolution Testing
- 20 Change Control and SUPAC
- 21 Process Validation and Quality Assurance
- 22 Validation in Contract Manufacturing
- 23 Terminology of Nonaseptic Process Validation
- 24 Harmonization, GMPs, and Validation
- Index