Validation of Pharmaceutical Processes

INTRODUCTION
Why Validation?, Robert G. Kieffer and Joseph D. Nally
Organizing for Validation, Ronald J. Simko
Validation and Facility Design, J. Robert Adamson

SUPPORT AND UTILITY SYSTEMS
Calibration and Certification, Robert E. Bremmer
Design, Installation, and Calibration of Thermocouple Measuring Systems, Clarence A. Kemper
Qualification and Change Control, Bohdan M. Ferenc
Monitoring of Nonviable Particles, Alvin Lieberman
Viable Environmental Microbiological Monitoring, Pamela D. Deschenes
Validation of Environmental Control Systems Used in Parenteral Facilities, Franco De Vecchi
Validation of Utilities, Barry D. Garfinkle
The Validation of Pharmaceutical Water Systems, Theodore H. Meltzer

STERILIZATION, SANITIZATION, AND STERILITY ASSURANCE
Microbiology of Sterilization Processes, Timothy J. Leahy, Kerry L. Roche, and Maura R. Christopher
F, D, and Z Values, John Shirtz
Validation of Steam Sterilization in Autoclaves, Phil DeSantis
Steam Sterilization-in-Place Technology and Validation, James P. Agalloco
Dry-Heat Sterilization and Depyrogenation, Laurie B. Colman and Gayle D. Heffernan
Validation of Gas Sterilization, David F. Bekus
Validation of Radiation Sterilization Processes, John F. Reger
Validation of Sterilizing-Grade Filters, John McGrath and Richard Levy
Validation of Unique Filtration Processes, Carole S. Genovesi
Disinfectants, James D. Wilson
Cleaning and Sanitization of Cleanrooms and Materials, Anne Marie Dixon
Validation of Aseptic Processing, James P. Agalloco and James E. Akers

STERILE PRODUCT MANUFACTURING
Component Preparation Processes, Dominic A. Ventura and Stephen W. Goodsir
Validation of Lyophilization, Edward H. Trappler
Validation of Packaging Operations, Charles S. Levine
Retrospective Validation, James P. Agalloco
Regulatory Aspects of Validation, Ralph Badagliacca
Process Control and Quality Systems for a Changing World, James E. Akers