Handbook of Validation in Pharmaceutical Processes, Fourth Edition by Phil DeSan

Description: FREE SHIPPING UK WIDE Handbook of Validation in Pharmaceutical Processes, Fourth Edition by Phil DeSantis, Anthony Grilli, Anthony Pavell, James Agalloco 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. FORMAT Paperback LANGUAGE English CONDITION Brand New Publisher 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 industrys 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 sterilizationIdentifies obstacles that may be encountered at any stage of the validation program, and suggests the newest and most advanced solutionsExplores distinctive and specific process steps, and identifies critical process control points to reach acceptable resultsNew chapters include disposable systems, combination products, nano-technology, rapid microbial methods, contamination control in non-sterile products, liquid chemical sterilization, and medical device manufacture Author Biography 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. 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 Details ISBN0367756064 Author James Agalloco Language English ISBN-10 0367756064 ISBN-13 9780367756062 Publisher Taylor & Francis Ltd Year 2024 Publication Date 2024-08-26 Place of Publication London Country of Publication United Kingdom DEWEY 615.19 UK Release Date 2024-08-26 Pages 1043 Edition 4th Format Paperback Edited by Anthony Pavell Illustrations 198 Tables, black and white; 172 Line drawings, black and white; 58 Halftones, black and white; 230 Illustrations, black and white Edition Description 4th edition Imprint CRC Press Alternative 9780367754297 Audience Tertiary & Higher Education We've got this At The Nile, if you're looking for it, we've got it. With fast shipping, low prices, friendly service and well over a million items - you're bound to find what you want, at a price you'll love! 30 DAY RETURN POLICY No questions asked, 30 day returns! FREE DELIVERY No matter where you are in the UK, delivery is free. SECURE PAYMENT Peace of mind by paying through PayPal and eBay Buyer Protection TheNile_Item_ID:161897039;

Price: 69.86 GBP

Location: London

End Time: 2024-12-28T14:51:50.000Z

Shipping Cost: 16.45 GBP