58Information accompanying the application

58 Information accompanying the application

(1) The application must contain, or be accompanied by, a diagram of the applicant’s organisational reporting structure for manufacturing and for quality control. (2) The application must also contain, or be accompanied by: (a) a diagram of the buildings on the primary, secondary and tertiary premises and their functions, and the activities carried out on adjacent premises; and (b) diagrams of the buildings to be used for manufacture, storage and quality control, identifying major plant items and equipment, the activities carried out in each room, and all entrances and exits, and explaining the various steps in the manufacturing process; and (c) a description of, and the specifications for, each controlled air system at the manufacturing premises; and (d) details of each cleanroom at the premises (including their grade, number of air changes per hour and pressure gradients). (3) If a primary, secondary or tertiary premises is licenced or certified (or similar) for compliance with good manufacturing practice or relevant recognised quality standard by the Therapeutic Goods Administration or the National Association of Testing Authorities, Australia, the application must contain, or be accompanied by: (a) a copy of the licence or certification (or similar), including any schedules or attachments; and (b) a copy of the most recent inspection report and closure advice.