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Synopsis
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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Review
"easy to read and informative.an excellent blend of theoretical knowledge and applied practical considerations." -American Journal of Pharmaceutical Education "this comprehensive bookwillprove very useful to those designing a facility for producing sterile and nonsterile productsa good mix of the theoretical and applied." -Irish Pharmacy Journal "an excellent presentation on the subject of validation of pharmaceutical processes related to sterile products. It is written in a simple language and can be easily understood at the same time without losing the importance of the subject. The book will be an asset to education institutions in pharmacy and pharmaceutical technology, project and manufacturing personnel of sterile product manufacturing organisations and also to quality assurance and R&D personnel." -Pharmatimes "overwhelmingly valuable to anyone who has anything at all to do with the manufacture of sterile products, or with the processes associated with their production." - Pharmaceutical Development and Technology Promo Copy
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