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. This book blends the use of theoretical knowledge with recent technological advancements to achieve applied practical solutions. As the industry's leading source for validation of sterile pharmaceutical processes for more than 10 years, this greatly expanded work is a comprehensive analysis of all the fundamental elements of pharmaceutical and bio-pharmaceutical production processes. Handbook of Validation in Pharmaceutical Processes, Fourth Edition is essential for all global health care manufacturers and pharmaceutical industry professionals.
Key Features:
- Provides an in-depth discussion of recent advances in sterilization
- Identifies obstacles that may be encountered at any stage of the validation program, and suggests the newest and most advanced solutions
- Explores distinctive and specific process steps, and identifies critical process control points to reach acceptable results
- New chapters include disposable systems, combination products, nano-technology, rapid microbial methods, contamination control in non-sterile products, liquid chemical sterilization, and medical device manufacture
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
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 USPs Microbiology and Sterility Assurance Expert Committee for 2005-2015. He is a frequent author and lecturer on sterilization, aseptic processing and process validation.
Biežāk uzdotie jautājumi par e-grāmatām