Execution of manufacturing facility acceptance testing (FAT) and site acceptance testing (SAT) is a business-critical activity In regards to commissioning of a whole new technique or devices. The International Society for Pharmaceutical Engineering (ISPE) defines FAT and SAT since the inspection and static and/or dynamic testing of producing method
This document discusses production functions and controls to avoid blend-ups and cross contamination. It outlines precautions like correct air managing, segregated locations, and status labeling. Processing of intermediates and bulk products and solutions have to be documented and checks set set up to make sure excellent like verifying identity and
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Protection requirements define distinct procedures, tactics, and system style and design procedures to the prevention of unauthorized entry and use. Typically, these requirements document:To keep the requirements-accumulating procedure streamlined, you may accumulate some inputs through a questionnaire and invite a smaller team of men and women to
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