Execution of manufacturing unit acceptance testing (Body fat) and site acceptance testing (SAT) is a business-essential activity With regards to commissioning of a whole new method or machines. The Intercontinental Culture for Pharmaceutical Engineering (ISPE) defines Body fat and SAT as the inspection and static and/or dynamic testing of manufactu

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At last, if third events have been associated with the development and qualification of analytical methods, a perfectly-developed technological transfer and correct documentation are necessary for keeping the qualification position following the transfer from the method and also to permit the validation readiness assessment exercise prior to ICH va