Validation of Pharmaceutical Processes: Sterile Products, Second Edition

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Validation of Pharmaceutical Processes: Sterile Products, Second EditionFeaturing contributions from 25 specialists, this book provides a single source reference on the design of systems, qualification of equipment, calibration and certification. It covers explicit procedures for the validation of systems required in the preparation of aseptic and nonaseptic pharmaceutical products. Topics include installation qualification, operational qualification, and change control, F, D, and Z values, steam sterilization in place

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