Helping researchers avoid obstacles that may be encountered at any stage of the validation process, this authoritative Third Edition contains new chapters on validation in multinational and small companies, process analytical technology, and international validation methods - detailing the design of systems, the qualification of equipment, processes in calibration and certification, and procedures for the validation of systems for the preparation of aseptic and non-aseptic pharmaceutical products.
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?