Revised to reflect significant advances in pharmaceutical production and regulatory expectations, Handbook of Validation in Pharmaceutical Processes, Fourth Edition examines and blueprints every step of the validation process needed to remain compliant and competitive.
Revised to reflect significant advances in pharmaceutical production and regulatory expectations, Handbook of Validation in Pharmaceutical Processes, Fourth Edition examines and blueprints every step of the validation process needed to remain compliant and competitive.
James Agalloco is President of Agalloco & Associates, a technical service firm to the pharmaceutical and biotechnology industry. He was previously Director, Worldwide Validation and Automated Technology for Bristol-Myers Squibb. He received his BS in Chemical Engineering from Pratt Institute in 1968 and his MS, also in Chemical Engineering from Polytechnic Institute of New York in 1979. He received his MBA in Pharmaceutical Studies from Fairleigh Dickinson University in 1983. He is a past President of the Parenteral Drug Association and served as an Officer or Director from 1982 to 1993. He is a member of USP's Microbiology and Sterility Assurance Expert Committee for 2005-2015. He is a frequent author and lecturer on sterilization, aseptic processing and process validation.
Inhaltsangabe
1. Why Validation? 2. Facility Design for Validation 3. Modular Facilities - Meeting the Need for Flexibility 4. Commissioning and Qualification 5. Design & Quaification of Controlled Environments 6. Validation of Pharmaceutical Water Systems 7. Validation of Critical Utilities 8. Calibration and Metrology 9. Risk Management and Thermal Validation 10. Change Control 11. MICROBIOLOGY OF STERILIZATION PROCESSES 12. Biological Indicators 13. Steam Sterilization in Autoclaves 14. Validation of Terminal Sterilization 15. Steam Sterilization-in-Place Technology and Validation 16. Dry Heat Sterilization 17. Depyrogenation by Inactivation and Removal 18. Ethylene Oxide Sterilization 19. Validation of chlorine dioxide Sterilization 20. Liquid Phase Sterilization 21. Vapor Sterilization and Decontamination 22. Validation of the Radiation Sterilization of Pharmaceuticals 23. Validation of Sterilizing Grade Filters 24. Disinfecting Agents: The Art of Disinfection 25. Cleaning and Disinfecting Laminar Flow Workstations Bio Safety Cabinets and Fume Hoods 26. Contamination Control for Component Introduction to Classified Areas 27. Aseptic Processing for Dosage Form Manufacture 28. Validation of Manual Aseptic Processes 29. Validation of Aseptic Processing for Bulk Pharmaceutical Chemicals 30. Qualification and Validation of Advanced Aseptic Processing Technologies 31. Total Particle Monitoring 32. Environmental Monitoring 33. Validation of Container Component Preparation 34. Validation of Lyophilization 35. Validation of Packaging Processes for Sterile Products 36. Validation of Active Pharmaceutical Ingredients 37. Cell Culture Process Validation including Cell Bank Qualification 38. Validation of Recovery and Purification Processes 39. Validation of Process Chromatography 40. Single Use Technologies and Systems 41. Considerations for Process Validation for Cell and Gene Therapies 42. Validation of Solid Dosage Forms 43. Validation of Validation of Oral / Topical Liquids & Semi-Solids 44. Validation of Non-Sterile Packaging Operations 45. Validation of Cleaning Processes 46. Validation of Training 47. Vendor Qualification and Validation 48. Validation of Clinical Trial Manufacturing 49. Validation of New Products 50. Retrospective / Continuous Process Validation 51. Validation & 6 Sigma 52. Validation and Contract Manufacturing 53. Computerized Systems Validation 54. Risk Based Validation of Laboratory Information Management Systems 55. Control Systems Validation 56. Process Analytical Technology and Validation 57. Validation of Analytical Procedures and Physical Methods 58. Validation of Microbial Methods 59. "Rapid Methods for Aseptic Processing and Their Validation" 60. Extractables and Leachables in Drug Products: An Overview 61. Evolution and Implementation of Validation in the United States 62. Validation in Europe - What are the Differences? 63. Japanese Approach to Validation 64. Organization of Validation in a MultiNational Pharmaceutical Company 65. Validation in a Small Pharmaceutical Company 66. Regulatory Aspects of Process Validation in the United States 67. The Future of Validation
1. Why Validation? 2. Facility Design for Validation 3. Modular Facilities - Meeting the Need for Flexibility 4. Commissioning and Qualification 5. Design & Quaification of Controlled Environments 6. Validation of Pharmaceutical Water Systems 7. Validation of Critical Utilities 8. Calibration and Metrology 9. Risk Management and Thermal Validation 10. Change Control 11. MICROBIOLOGY OF STERILIZATION PROCESSES 12. Biological Indicators 13. Steam Sterilization in Autoclaves 14. Validation of Terminal Sterilization 15. Steam Sterilization-in-Place Technology and Validation 16. Dry Heat Sterilization 17. Depyrogenation by Inactivation and Removal 18. Ethylene Oxide Sterilization 19. Validation of chlorine dioxide Sterilization 20. Liquid Phase Sterilization 21. Vapor Sterilization and Decontamination 22. Validation of the Radiation Sterilization of Pharmaceuticals 23. Validation of Sterilizing Grade Filters 24. Disinfecting Agents: The Art of Disinfection 25. Cleaning and Disinfecting Laminar Flow Workstations Bio Safety Cabinets and Fume Hoods 26. Contamination Control for Component Introduction to Classified Areas 27. Aseptic Processing for Dosage Form Manufacture 28. Validation of Manual Aseptic Processes 29. Validation of Aseptic Processing for Bulk Pharmaceutical Chemicals 30. Qualification and Validation of Advanced Aseptic Processing Technologies 31. Total Particle Monitoring 32. Environmental Monitoring 33. Validation of Container Component Preparation 34. Validation of Lyophilization 35. Validation of Packaging Processes for Sterile Products 36. Validation of Active Pharmaceutical Ingredients 37. Cell Culture Process Validation including Cell Bank Qualification 38. Validation of Recovery and Purification Processes 39. Validation of Process Chromatography 40. Single Use Technologies and Systems 41. Considerations for Process Validation for Cell and Gene Therapies 42. Validation of Solid Dosage Forms 43. Validation of Validation of Oral / Topical Liquids & Semi-Solids 44. Validation of Non-Sterile Packaging Operations 45. Validation of Cleaning Processes 46. Validation of Training 47. Vendor Qualification and Validation 48. Validation of Clinical Trial Manufacturing 49. Validation of New Products 50. Retrospective / Continuous Process Validation 51. Validation & 6 Sigma 52. Validation and Contract Manufacturing 53. Computerized Systems Validation 54. Risk Based Validation of Laboratory Information Management Systems 55. Control Systems Validation 56. Process Analytical Technology and Validation 57. Validation of Analytical Procedures and Physical Methods 58. Validation of Microbial Methods 59. "Rapid Methods for Aseptic Processing and Their Validation" 60. Extractables and Leachables in Drug Products: An Overview 61. Evolution and Implementation of Validation in the United States 62. Validation in Europe - What are the Differences? 63. Japanese Approach to Validation 64. Organization of Validation in a MultiNational Pharmaceutical Company 65. Validation in a Small Pharmaceutical Company 66. Regulatory Aspects of Process Validation in the United States 67. The Future of Validation
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