| Description |
1 online resource (762 pages) |
| Contents |
Front cover; Preface; Contents; Contributors; List of Abbreviations; Section I: Introduction; Chapter 1. Why Validation?; Chapter 2. Organizing for Validation; Chapter 3. Validation and Facility Design; Section II: Support and Utility Systems; Chapter 4. Validation of Environmental Control Systems Used in Parenteral Facilities; Chapter 5. Validation of Critical Utilities; Chapter 6. The Validation of Pharmaceutical Water Systems; Chapter 7. Caliberation and Metrology; Chapter 8. Temeprature Meaurements; Chapter 9. Qualification and Change Control |
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Section III: Sterilization, Sanitization, and Sterility AssuranceChapter 10. Microbiology of Sterilization Processes; Chapter 11. F, D, and z Values; Chapter 12. Steam Sterilization in Autoclaves; Chapter 13. Validation of Terminal Sterilization; Chapter 14. Steam Sterilization-in-Place Technology and Validation; Chapter 15. Dry Heat Sterilization and Depyrogenation Validation and Monitoring; Chapter 16. Validation of Ethylene Oxide Sterilization Processes; Chapter 17. Validation of Chlorine Dioxide Sterilization; Chapter 18. Validation of the Radiation Sterilization of Pharmaceuticals |
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Chapter 19. Isolator DecontaminationChapter 20. Validation of Sterilizing-Grade Filters; Chapter 21. Cleaning and Disinfection in the Control of Pharmaceutical Cleanrooms; Chapter 22. Aseptic Processing for Dosage Form Manufacture: Organization and Validation; Chapter 23. Validation of Aspectic Processing for Bulk Pharmaceutical Chemicals; Chapter 24. Validation of Manual Aseptic Processes; Section IV: Sterile Product Manufacturing; Chapter 25. Monitoring of Nonviable Particles; Chapter 26. Viable Environmental Microbiological Monitoring |
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Chapter 27. Validation of Container Preparation ProcessesChapter 28. Validation of Lyophilization; Chapter 29. Qualifaction Concerns for Isolator Systems; Section V: Secondary Manufacturing; Chapter 30. Validation of Solid Dosage Finished Goods; Chapter 31. Validation of Oral/Topical Liquids and Semisolids; Chapter 32. Validation of Packaging Operations; Section VI: Primary Manufacturing; Chapter 33. Validation of Bulk Pharmaceutical Chemicals; Chapter 34. Validation of Recovery and Purification Processes; Chapter 35. Validation of Process Chromatography |
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Chapter 36. Cell Culture Process ValidationSection VII: Manufacturing Related Activities; Chapter 37. Cleaning Validation for the Pharmaceutical, Biopharmaceutical, Cosmetic, Nutraceutical, Medical Device, and Diagnostic Industries; Chapter 38. Validation of Training; Chapter 39. Vendor Qualification and Validation; Chapter 41. Validation of New Products; Chapter 42. Retrospective Validation; Chapter 43. Validation and Six Sigma; Chapter 44. Validation and Contract Manufacturing; Section VIII: Computerized Systems; Chapter 45. Process Analytical Technology and Validation |
| Summary |
Completely revised and updated to reflect the significant advances in pharmaceutical production and regulatory expectations, this third edition of Validation of Pharmaceutical Processes examines and blueprints every step of the validation process needed to remain compliant and competitive. The many chapters added to the prior compilation examine validation and six sigma system design; the preparation of aseptic and non-aseptic pharmaceutical products; active pharmaceutical ingredient and biotechnology processes, computerized systems; qualification and cleaning of equipment; analytical methods |
| Notes |
Chapter 46. Computerized Systems Validation |
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Print version record |
| Subject |
Sterilization.
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Pharmaceutical technology -- Quality control
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Pharmaceutical technology -- Standards
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Pharmaceutical technology -- Quality control.
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Pharmaceutical technology -- Standards.
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Sterilization.
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| Form |
Electronic book
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| ISBN |
9781420019797 |
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1420019791 |
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