Pharmaceutical Process Validation
Crc Press Inc (Verlag)
978-0-8247-0838-2 (ISBN)
Robert A. Nash, Alfred H. Wachter
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.
| Erscheint lt. Verlag | 27.3.2003 |
|---|---|
| Reihe/Serie | Drugs and the Pharmaceutical Sciences |
| Verlagsort | Bosa Roca |
| Sprache | englisch |
| Maße | 152 x 229 mm |
| Gewicht | 1600 g |
| Themenwelt | Medizin / Pharmazie ► Medizinische Fachgebiete ► Pharmakologie / Pharmakotherapie |
| Medizin / Pharmazie ► Pharmazie | |
| Technik | |
| ISBN-10 | 0-8247-0838-5 / 0824708385 |
| ISBN-13 | 978-0-8247-0838-2 / 9780824708382 |
| Zustand | Neuware |
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