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. The many chapters added to the prior compilation 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. As the industry's leading source for validation of sterile pharmaceutical processes for more than 10 years, this greatly expanded is a comprehensive analysis of all of the fundamental elements of this arena with practical solutions for every pharmaceutical and bio-pharmaceutical production process.
Presenting theoretical knowledge and applied practical considerations, this title
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
Table of Contents
Validation of Pharmaceutical Processes, 3E. Why Validation. Organizing for Validation. Validation and Facility Design. Validation of Environmental Control Systems Used in Parenteral Facilities. Validation of Critical Utilities. The Validation of Pharmaceutical Water Systems. Calibration and Metrology. Temperature Measurements. Qualification & Change Control. Microbiology of Sterilization Processes. F, D, and z Values. Steam Sterilization in Autoclaves. Validation of Terminal Sterilization. Steam Sterilization-in-Place Technology and Validation. Dry Heat Sterilization and Depyrogenation Validation and Monitoring. Validation of Ethylene Oxide Sterilization Processes. Validation of Chlorine Dioxide Sterilization. Validation of the Radiation Sterilization of Pharmaceuticals. Isolator Decontamination.
Validation of Sterilizing-Grade Filters. Cleaning and Disinfection in the Control of Pharmaceutical Cleanrooms. Process Simulation. Validation of Aseptic Processing for Bulk Pharmaceutical Chemicals. Validation of Manual Aseptic Processes. Monitoring of Non-viable Particles. Monitoring of Viable Particles. Validation of Component Preparation. Validation of Lyophilization. Qualification Concerns for Isolator Systems.
Validation of Solid Dosage Finished Goods. Validation of Validation of Oral / Topical. Liquids & Semi-Solids. Validation of Packaging Operations. Validation of Bulk Chemical Processes. Validation of Recovery and Purification Processes. Validation of Process Chromatography. Cell Culture Process Validation. Cleaning Validation for the Pharmaceutical, Biopharmaceutical, Cosmetic, Nutraceutical, Medical Device and Diagnostic Industries. Validation of Training. Vendor Validations. Validation for Clinical Manufacturing. Validation of New Products. Retrospective Validation
Validation and Six Sigma. Validation and Contract Manufacturing. Process Analytical Technology and Validation. Computerized Systems Validation. Validation of Control Systems. Risk Based Validation of a Laboratory Information Management System (LIMS). Validation of Laboratory Information Systems. Validation of Analytical Procedures and Physical Methods. Validation of Microbiological Methods. Implementation of Validation in the United States. The European Approach to Validation - A Microbiological Perspective. Japanese Approach to Validation
Managing Validation in a Multi-National Company. Validation in a Small Pharmaceutical Company. Regulations and Validation. Validation - Whats Next?