The Validation process, imposed by regulatory authorities, require that drugs are produced, stored and handled in a validated system.
The advantages of BIM technology (Building Information Modeling) that involves 3D and parametric modeling of all architectural, structural and building system informations.
The building costs of a pharmaceutical plant are greatly influenced by the choices and decisions made during the final design phase.
The most subtle and potentially dangerous threats for the building’s budget and deadlines, don’t depends on technological aspects but they origin from engineering authorization processes.
The pharmaceutical sector is strongly regulated, and the drug production permits only “Zero risks”.
In this minefield the “ANNEX 1” represents the Bible.