Premises and Facilities: (i) layout of premises with indication of scale; (ii) nature of construction, finishes/ fixtures and fittings; (iii) brief description of ventilation systems. More details should be given for critical areas with potential risks of airborne contamination (including schematic drawings of the systems). Classification of the rooms used for the manufacture of sterile products should be mentioned; (iv) special areas for the handling of highly toxic, hazardous and sensitizing materials; (v) brief description of water systems (schematic drawings of the systems are desirable) including sanitation; (vi) maintenance (description of planned preventive maintenance programmes for premises and recording system). 4. Equipment: (i) brief description of major production and quality control laboratories equipment (a list of the equipment is required); (ii) maintenance (description of planned preventive maintenance programmes and recording system); (iii) qualification and calibration, including the recording system. Arrangements for computerized systems validation.