TY  - BOOK
AU  - Nash,Robert A.
AU  - Wachter,Alfred H.
TI  - Pharmaceutical Process Validation: an International
T2  - Drugs and the Pharmaceutical Sciences
SN  - 1135542872
PY  - 2003///
CY  - Hoboken
PB  - CRC Press
KW  - Pharmaceutical industry
KW  - Quality control
KW  - Drugs
KW  - Standards
KW  - United States
KW  - Inspection
KW  - Drug Evaluation
KW  - standards
KW  - Drug Industry
N1  - Includes bibliographical references and index; 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 SystemsChapter 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 AssuranceChapter 22. Validation in Contract Manufacturing; Chapter 23. Terminology of Nonaseptic Process Validation; Chapter 24. Harmonization, GMPs, and Validation; Index; Back Cover
N2  - 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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ER  -