This system includes the measures and activities which provide an appropriate physical environment and resources used in the production of the drugs or drug products. It includes buildings and facilities along with maintenance, equipment qualifications (installation and operation) equipment calibration and preventative maintenance; and cleaning and validation of cleaning processes as appropriate. Process performance qualification will be evaluated as part of the inspection of the overall process validation which is done within the system where the process is employed and, utilities that are not intended to be incorporated into the product such as HVAC, compressed gases, steam and water systems.