Pharmaceutical Process Validation offers step-by-step guidelines for the design and optimization of validation schemes and the qualification of facilities, equipment, and support systems utilized during pharmaceutical product/process development.

This edition contains new chapters covering:

• troubleshooting procedures
• validation in contract manufacturing
• current harmonization trends

Contents

1. Regulatory Basis for Process Validation
2. Prospective Process Validation
3. Retrospective Process Validation
4. Sterilization Validation
5. Validation of Solid Dosage Forms
6. Validation of Medical Devices
7. Validation of Biotechnology Processes
8. Transdermal Process Validation
9. Validation of Lyophilized Products
10. Validation of Inhalation of 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. Analytical Methods Validation
16. Computer Systems Validation
17. Integrated Packaging Validation
18. Analysis of Process Data Using Quality Control Charts
19. Statistical Methods for Blend Uniformity and Dissolution Testing
20. Change Control and SUPAC
21. Process Validation and Quality Assurance
22. Validation in Contract Manufacturing
23. Terminology on Non-Aseptic Process Validation
24. Harmonization, GMPs, and Validation

Index

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