Handbook of Validation in Pharmaceutical Processes, Fourth Edition

ISBN-13: 9780367754297 / Angielski / Twarda / 2021 / 1043 str.

James Agalloco; Phil DeSantis; Anthony Grilli

Opis

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.

Spis treści

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

O autorze

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.