Pharmaceutical Process Validation: An International: Drugs and the Pharmaceutical Sciences

Regulatory basis for process validation, John M. Dietrick and Bernard T. Loftus; prospective process validation, Allen Y. Chao, F. St Forbes, and Reginald F. Johnson; retrospective process validation, Chester J. Trubinski; sterilization validation, Michael J. Akers and Neil R. Anderson; validation of solid dosage forms, Jeffrey S. Rudolph and Robert J. Sepeljak; validation of medical devices, Toshiaki Nishihata; validation of biotechnology processes, Gail Sofer; transdermal process validation, Charlie Neal, Jr; validation of lyophilized products, Edward H. Trappler; validation of inhalation of aerosols, Chris Sciarra and John Sciarra; process validation of pharmaceutical ingredients, Robert A. Nash; qualification of water and air handling systems, Kunio Kawamura; equipment and facility qualification, Tom Peither; validation and verification of cleaning processes, William E. Hall; analytical methods validation, Ludwig Huber; computer systems validation, Tony de Claire; integrated packaging validation, Mervyn J. Frederick; analysis of process data using quality control charts, Peter Cheng and John Dutt; statistical methods for blend uniformity and dissolution testing, Bergum and Utter; change control and SUPAC, Nellie H. Waterland and Christopher C. Kowtna; process validation and quality assurance; Carl B. Rifino; validation in contract manufacturing, Dilip M. Parikh; terminology on non-aseptic process validation, Kenneth G. Chapman; harmonization, GMPs, and validation, Alfred Wachter.

Robert A. Nash, Alfred H. Wachter

Pharmaceutical Process Validation, Third Edition explores the roots of pharmaceutical process validation originating in Switzerland and Germany in the 1980s. It covers troubleshooting procedures, validation in contract manufacturing, and harmonization trends. New chapters include Validation for Medical Devices, Validation of Biotechnology Processes, Transdermal Process Validation, Integrated Packaging Validation, Statistical Methods for Uniformity and Dissolution Testing, Change Control and SUPAC, Validation in Contract Manufacturing, and Harmonization, GMPs, and Validation. It includes contributions by research and industry specialists from the U.S., Europe, and Japan.