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