Validation of Pharmaceutical Processes, Fourth Edition

Working Table of Contents - Do Not Post - Introduction.Why Validation. Organizing for Validation. Validation and Facility Design. Support and Utility Systems.Validation of Environmental Control Systems Used in Parenteral Facilities. Validation of Critical Utilities. The Validation of Pharmaceutical Water Systems. Calibration and Metrology. Temperature Measurements. Qualitfication and Change Control. Sterilization, Sanitization, and Sterility Assurance. 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. Aseptic Processing for Dosage Form Manufacturing: Organization and Validation. Validation of Aseptic Processing for Bulk Pharmaceutical CHemicals. Validation of Manual Aseptic Processes. Sterile Product Manufacturing. Monitoring of Nonviable Particles. Viable Environmental Microbiological Monitoring. Validation of Container Preparation Processes. Validation of Lyophilization. Qualification Concerns for Isolator Systems. Secondary Manufacturing. Validation of Solid Dosage Finished Goods. Validation of Oral/Topical Liquids and Semisolids. Validation of Packaging Operations. Primary Manufacturing. Validation of Bulk Pharmaceutical Chemicals. Validation of Recovery and Purification Processes. Validation of Process Chromatography. Cell Culture Process Validation. Manufacturing Related Activities. Cleaning Validation for the Pharmaceuticl, Biopharmaceutical, Cosmetic, Nutraceutical, Medical Device, and DIsgnostic Industries. Validation of Training. Vendor Qualifications and Validation. Validation for Clinical Manufacturing. Validation of New Products., Retrospective Validation. Validation and SIx Sigma. Validation and Contract Manufacturing. Computerized Systems. Process Analytical Technology and Validation. Computerized Systems Validation. Validation and Control Systems. Risk-Based Validation of a Laboratory Information Management SYstem. Validation of Laboratory Information Systems. Laboratory Methods and Quality Assurance. Validation of Analytical Procedures and Physical Methods. Validation of Microbiological Methods. General Topics. Implementation of Validation in the United States. The european Approach to Validation-A Microbiological Perspective. Japanese Regulatory Requirements. Managing Validation in a MUltinational COmpany. Validation in a Small Pharmaceutical COmpany. Regulatory Aspects of Validation. Validation-What's Next?