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Pharmaceutical Processes Validation Handbook
from C.H.I.P.S.

Validation of Pharmaceutical Processes
Third edition
edited by James P. Agalloco

Completely revised and updated to reflect the significant advances in pharmaceutical production and regulatory expectations, this third edition of Validation of Pharmaceutical Processes examines and blueprints every step of the validation process needed to remain compliant and competitive.

As the industry's leading source for validation of sterile pharmaceutical processes for more than 10 years, this greatly expanded edition is a comprehensive analysis of all of the fundamental elements of this arena with practical solutions for every pharmaceutical and bio-pharmaceutical production process.

New chapters in this edition examine:

  • validation and six sigma system design
  • the preparation of aseptic and non-aseptic pharmaceutical products
  • active pharmaceutical ingredient and biotechnology processes, computerized systems
  • qualification and cleaning of equipment
  • analytical methods, calibration and certification

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
  • blends the use of theoretical knowledge with recent technological advancements to achieve applied practical solutions

Contents

  1. Why Validation?
  2. Organizing for Validation
  3. Validation and Facility Design
  4. Validation of Environmental Control Systems Used in Parenteral Facilities
  5. Validation of Critical Utilities
  6. The Validation of Pharmaceutical Water Systems
  7. Calibration and Metrology
  8. Temperature Measurements
  9. Qualification & Change Control
  10. Microbiology of Sterilization Processes
  11. F, D, and z Values
  12. Steam Sterilization in Autoclaves
  13. Validation of Terminal Sterilization
  14. Steam Sterilization-in-Place Technology and Validation
  15. Dry Heat Sterilization and Depyrogenation Validation and Monitoring
  16. Validation of Ethylene Oxide Sterilization Processes
  17. Validation of Chlorine Dioxide Sterilization
  18. Validation of the Radiation Sterilization of Pharmaceuticals
  19. Isolator Decontamination
  20. Validation of Sterilizing-Grade Filters
  21. Cleaning and Disinfection in the Control of Pharmaceutical Cleanrooms
  22. Process Simulation
  23. Validation of Aseptic Processing for Bulk Pharmaceutical Chemicals
  24. Validation of Manual Aseptic Processes
  25. Monitoring of Non-viable Particles
  26. Monitoring of Viable Particles
  27. Validation of Component Preparation
  28. Validation of Lyophilization
  29. Qualification Concerns for Isolator Systems
  30. Validation of Solid Dosage Finished Goods
  31. Validation of Oral/Topical Liquids & Semi-Solids
  32. Validation of Packaging Operations
  33. Validation of Bulk Chemical Processes
  34. Validation of Recovery and Purification Processes
  35. Validation of Process Chromatography
  36. Cell Culture Process Validation
  37. Cleaning Validation for the Pharmaceutical, Biopharmaceutical, Cosmetic, Nutraceutical, Medical Device and Diagnostic Industries
  38. Validation of Training
  39. Vendor Validations
  40. Validation for Clinical Manufacturing
  41. Validation of New Products
  42. Retrospective Validation
  43. Validation and Six Sigma
  44. Validation and Contract Manufacturing
  45. Process Analytical Technology and Validation
  46. Computerized Systems Validation
  47. Validation of Control Systems
  48. Risk Based Validation of a Laboratory Information Management System (LIMS)
  49. Validation of Laboratory Information Systems
  50. Validation of Analytical Procedures and Physical Methods
  51. Validation of Microbiological Methods
  52. Implementation of Validation in the United States
  53. The European Approach to Validation - A Microbiological Perspective
  54. Japanese Approach to Validation
  55. Managing Validation in a Multi-National Company
  56. Validation in a Small Pharmaceutical Company
  57. Regulations and Validation
  58. Validation - Whats Next?

Index

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Validation of Pharmaceutical Processes
Third edition
edited by James P. Agalloco

2007 • 760 pages • $355.00 + shipping
Texas residents please add 6.75 % sales tax

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