Validation of Pharmaceutical Processes: Sterile Products, Second Edition
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Validation of Pharmaceutical Processes: Sterile Products, Second Edition
BOOK DETAIL
Amazon Business : Save 25% off first $200 of business supplies. Register a free business account Hardcover: 856 pages Publisher: CRC Press; 2 edition (November 5, 1998) Language: English ISBN-10: 0824793846 ISBN-13: 978-0824793845 Product Dimensions: 7.5 x 1.8 x 10.5 inches Shipping Weight: 3.1 pounds
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Book Description
Featuring 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 technology and validation, sterilization methods, protocols that allow procedures to be applied directly, obstacles that may be encountered at any stage of the validation program, and suggested solutions.
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