Pharmaceutical process validation
著者
書誌事項
Pharmaceutical process validation
（Drugs and the pharmaceutical sciences, v. 129）
Marcel Dekker, c2003
International 3rd edition, revised and expanded
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注記
Includes bibliographical references and index
内容説明・目次
内容説明
The third edition of this text contains additional chapters which cover troubleshooting procedures, validation in contract manufacturing and current harmonization trends.
目次
- 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.
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