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Professional Pharmaceutical Guide from C.H.I.P.S.

Pharmaceutical Process Validation
Third Edition
edited by Robert A. Nash

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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Pharmaceutical Process Validation 3rd Edition
edited by Robert A. Nash and Alfred H. Wachter
860 pages Illustrated $298.95 + shipping
Texas residents please add 6.75 % sales tax

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