Validation Standard Operating Procedures
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Dodał/a książkę:Wojciech Polak
Expertly leading readers through the required validation standard operating procedures and documentation necessary for achieving compliance in the pharmaceutical industry, this sourceprovides 139 ready-to-use Master Validation procedures, template protocols, and reportssupplies a CD-ROM with a template of customizable validation standard operating proceduresincludes examples of 11 critical qualification and re-qualification reportspresents 14 exclusive environmental performance evaluation proceduresprovides the needed administrative solutions and guidance for achieving compliance with FDA requirements, and for obtaining authorization to market products in the United Statesincludes step-by-step guidelines for translating GMP requirements into action Spanning every critical element of validation for any pharmaceutical, diagnostic, medical device or equipment, and biotech product, this Second Edition guides readers through each step in the correct execution of validating processes required for non-aseptic and aseptic pharmaceutical production. With 14 exclusive environmental performance evaluations, it features 64 new protocols on topics such as sterility assurance, media fill guidelines, and environmental control.