pharmaceutical process validation an international 3rd Edition by Robert A Nash, Alfred H Wachter ISBN 0824708385 9780824708382

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Product details:

ISBN 10: 0824708385 
ISBN 13: 9780824708382
Author: Robert A Nash, Alfred H Wachter

pharmaceutical process validation an international 3rd Table of contents:

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

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Tags: Robert A Nash, Alfred H Wachter, pharmaceutical process