Personnel: (i) organisation chart showing the arrangements for key personnel; (ii) qualifications, experience and responsibilities of key personnel; (iii) outline of arrangements for basic and in-service training and how records are maintained; (iv) health requirements for personnel engaged in production; (v) personnel hygiene requirements, including clothing. Central Drugs Standard Control Organization, Ministry of Health and Family Welfare, Govt. of India Page 102 of 248 3. 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).