Handbook of Validation in Pharmaceutical Processes, Fourth Edition (eBook, PDF)

Redaktion: Agalloco, James; Pavell, Anthony; Grilli, Anthony; DeSantis, Phil

• Format: PDF

Produktbeschreibung

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.

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Produktdetails

• Verlag: Taylor & Francis
• Seitenzahl: 1061
• Erscheinungstermin: 28. Oktober 2021
• Englisch
• ISBN-13: 9781000436013
• Artikelnr.: 62517162

Autorenporträt

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