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    Handbook of Validation in Pharmaceutical Processes, Fourth Edition

    Handbook of Validation in Pharmaceutical Processes, Fourth Edition by Agalloco, James; DeSantis, Phil; Grilli, Anthony;

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    Estimated delivery time: In stock at the publisher, but not at Prospero's office. Delivery time approx. 3-5 weeks.
    Not in stock at Prospero.

    Why don't you give exact delivery time?

    Delivery time is estimated on our previous experiences. We give estimations only, because we order from outside Hungary, and the delivery time mainly depends on how quickly the publisher supplies the book. Faster or slower deliveries both happen, but we do our best to supply as quickly as possible.

    Product details:

    • Edition number 4
    • Publisher CRC Press
    • Date of Publication 26 August 2024

    • ISBN 9780367756062
    • Binding Paperback
    • No. of pages1061 pages
    • Size 279x216 mm
    • Weight 2680 g
    • Language English
    • Illustrations 230 Illustrations, black & white; 58 Halftones, black & white; 172 Line drawings, black & white; 198 Tables, black & white
    • 740

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    Short description:

    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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    Long description:

    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

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    Table of Contents:

    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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    Handbook of Validation in Pharmaceutical Processes, Fourth Edition

    Handbook of Validation in Pharmaceutical Processes, Fourth Edition

    Agalloco, James; DeSantis, Phil; Grilli, Anthony;(ed.)

    23 781 HUF

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