Establishment Standards for Veterinary Drugs Manufacturers Article 4

The buildings and the facilities of the premises shall comply with the following provisions:1.The buildings shall be firm, safe, clean, insect-free, mouse- free and dust- free; 2.The material of the interior wall, floor and ceiling shall be water resistant. The surface of the wall and floor shall remain level and smooth without any crevices or cracks by using cement, terrazzo, or plastic plate, ceramic tiles, or other neat materials which shall be easily cleaned without producing dust. It is necessary to use the material applicable for sterilization and washing. The floor shall be slanted appropriately to avoid partial water accumulation;3.The interior piling shall be made of a material which is dust-proof or filth-proof and shall be hidden;4.The drains shall be equipped with a wastewater anti-backflow device;5.The restroom and bathroom for operators shall be placed outside the manufacture area;6.The adequate washing-up device shall be placed outside the manufacture area and separated from the manufacture area;7.The sewage, garbage and other wastes shall be treated pursuant to a safe and healthy manner;8.The Manufacturer shall set the common water treatment, purified water treatment, boiler or distilled water manufacture facilities pursuant to the operating demands. The water supply facilities shall avoid polluting the products;9.The Manufacturer shall set the container washing facility; the washing facility of the ophthalmic, injection, and biomedicine or biotechnical containers shall be set independently to prevent pollution; and10.The animal rooms shall be separated appropriately under the animal categories, the properties of the manufacture and test tasks, and shall be kept from the manufacture and packaging area appropriately.
中文原文 動物用藥品製造廠設廠標準第4條
藥廠廠房之建築及設施應符合下列規定:
一、廠房之建築,應堅固、安全、清潔、防蟲、防鼠、防塵。
二、室內牆壁、地面及天花板應採用耐水材料,牆壁及地面應用水泥、磨石子或舖設塑膠板、瓷磚或其他光潔建築材料,表面應保持平滑而無裂痕及縫隙,且應易於清潔而不發生粉塵,必要時並應採用易於消毒清洗之材料。
地面應有適當傾斜,且無局部積水現象。
三、室內導管應選用表面不易積存塵埃或污垢之材料,並應力求隱蔽。
四、排水裝置之排水口應有防止廢水回流之設施。
五、工作場所外應設置供員工使用之休息室、浴室。
六、製造加工區域外應具備適當之盥洗設施;盥洗設施應與工作場所隔離。
七、污水、垃圾及其他廢棄物應以合乎衛生安全之方式處理。
八、藥廠應視作業需要設置一般用水處理、純化水處理、鍋爐或蒸餾水製造設施;供水設施應避免對產品造成污染。
九、藥廠應設置容器洗滌設施,對於眼用劑、注射劑及生物藥品或生物技術產品所用容器之洗滌設施,應注意防止污染,並獨立設置。
十、各動物室應依動物類別及製造、試驗工作性質予以適當區隔,並應與製造、分裝作業場所保持適當之隔離。

English translation for reference only; the Chinese text prevails. Not legal advice.