Pharmaceutical Process Validation: An International / Edition 3

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Pharmaceutical Process Validation, 3rd Ed. offers step-by-step guidelines for the design and optimization of validation schemes and the qualification of facilities, equipment, and support systems utilized during pharmaceutical product/process development. Contains new chapters covering troubleshooting procedures, validation in contract manufacturing, and current harmonization trends. Contains new chapters covering troubleshooting procedures, validation in contract manufacturing, and current harmonization trends. Features discussions on the validation of transdermal delivery systems, automation and computer systems, and oral inhalation products.

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Product Details

  • ISBN-13: 9780824708382
  • Publisher: Taylor & Francis
  • Publication date: 3/28/2003
  • Series: Drugs and the Pharmaceutical Sciences Series , #129
  • Edition description: REV
  • Edition number: 3
  • Pages: 776
  • Product dimensions: 6.10 (w) x 9.10 (h) x 1.80 (d)

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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