Pharmaceutical Process Validation

Pharmaceutical Process Validation : An International

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The third edition of this text contains additional chapters which cover troubleshooting procedures, validation in contract manufacturing and current harmonization trends.
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Product details

  • Hardback | 776 pages
  • 152 x 229 x 45.72mm | 1,315g
  • CRC Press Inc
  • Bosa Roca, United States
  • English
  • New edition
  • 3rd New edition
  • 0824708385
  • 9780824708382

Table of contents

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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