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Design stage where key design documents are generated to provide the framework of the detailed design process. These documents may include site plans, building floor plans, process and materials flow diagrams, air flow diagrams and HVAC schedules, rough utility and process piping routing drawings, and electrical one-line diagrams. The state HOW a facility or system is to perform.
Publication Source: ISPE Baseline® Guide, Vol. 3: Sterile Product Manufacturing Facilities (Second Edition)
Publication Date: 2011
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