Establishment Standards for Veterinary Drugs Manufacturers Article 5

The workplace of the Manufacturer shall follow to the provisions prescribed below:1.There shall be apparent partitions for the respective workplaces. The manufacture, processing and packaging workplaces shall be completely separated from the offices, reception rooms, laboratories, restaurants and toilets. Material vulnerable to pollution shall be avoided;2.There shall be adequate sizes and locations for places for storing raw material , product containers, caps, labeling and packaging materials and those for manufacture, processing, packaging and storing products; the preceding workplaces shall be appropriately arranged pursuant to the operations to prevent mix-up and contamination; 3.There shall be adequate work space, segmentation and cleanliness set up for diverse workplaces according to the suite; 4.The cleanliness shall be set up by ranks pursuant to the property of the manufacture; the workplaces with the same cleanliness shall be located in the same area. There shall be a buffer space or a prior room between the areas with diverse cleanliness where the diverse colors and uniforms may be used as the segmentation;5.There shall be a locker room, hand washer for operators, and washer or sterilizer for the uniforms, hats, masks, gloves and shoes at the entrances of the diverse workplaces. There shall be sufficient water supply and sterilizer for manufacturing the biomedicines;6.The manufacture area can not be the passageways for staff in other workplaces;7.The material flow and personal flow may not be shared commonly and intersected;8.There shall be sufficient illumination, ventilation and washers in each manufacture area9.There shall be adequate temperature and humidity controller in all workplaces if necessary; 10.As for the air supply in the manufacture and processing areas, there shall be a proper air filtration system in accordance with the cleanliness, including the pre-filter and particulate filter;11.The facilities in the process of manufacture, processing and packaging operation shall be a closed operation system from the incoming to outgoing slots in principle. Where the preceding operation system fails to be achieved, there shall be a partial exhaust facility and negative pressure operation if there is any dust or harmful gas produced;12.As for the workplaces where there is dust, organic solvents are used or dangerous articles are involved, the electric facilities shall be explosion-proof, fully closed or separated from the workplaces pursuant to the work demands; and13.The workplaces where the medicated feed additives are manufactured shall be separated completely from other workplaces if the cleanliness of the aforementioned workplaces affects the quality of other products.