Standards for Medicament Factory Establishments Article 4
Medicament factories shall possess the following basic requirements and common facilities:(1) Factory sites shall be situated in sanitary locations with fresh air; factory production, processing and packaging areas shall be constructed in accordance with relevant building codes, and located at a sufficient distance from factory boundaries to prevent pollution and fires; safety measures against pathogens implemented at factories and facilities that manufacture biopharmaceuticals or biotechnology products may not interfere with public health or safety; factory sewers shall be covered to prevent the entry and exit of animals to spread pathogens.(2) Factory buildings shall be solid and safe, and designed to prevent rodents, insects and dust; interior ceilings, walls and floors shall be smooth and free of cracks and crevices, easy to clean, and non-conducive to the collection of dust; where necessary, materials that are easily cleaned and disinfected may be used; all operation areas shall be well illuminated and ventilated; where necessary, equipment for the regulation of temperature, humidity and air clean may be installed.(3) Operation areas shall be clearly delineated (e.g. powder manufacturing room, liquid manufacturing room); in factories that environmental sanitation medicines are also manufactured, the operation areas shall be separated by an appropriate distance from manufacturing factories of other medicines; when necessary, separation walls may be installed.(4) Warehouses for the storage of raw materials, supplies, semi-finished products and end products shall be established.(5) There shall be facilities for the treatment of dust and powder, wastewater, hazardous wastes, toxic containers, hazardous gases, biological components and other hazardous components or materials.(6) There shall be weighing facilities that comply with regulations, and they shall be rectified regularly.(7) There shall be container washing facilities. Where container washing facilities are used in factories manufacturing eye drops, injectables and biopharmaceuticals or biotechnology products, special care shall be taken to prevent contamination, and said facilities shall be installed separately.(8) There shall be hand-washing facilities for employers, and facilities for the washing or sterilization of work clothes, caps, face masks, gloves and shoes. Employee lounges and shower rooms shall be established, as needed, outside of the operation areas; appropriate lavatory facilities shall be established in manufacturing and processing areas, separated from operation areas.(9) There shall be testing departments (laboratory and instrument room), and appropriate testing equipment. However, if tests are conducted on a contract basis by an organization approved by the competent authority, in accordance with the Contract Drug Manufacturing and Testing Operating Principles, and clear document is provided, establishment of said facilities may be waived.(10) For operation areas involving flammable or hazardous raw materials, solvents, semi-finished or intermediate products and finished products, appropriate protective, first-aid and segregation facilities shall be installed.Boilers, water pumps, vacuum pumps, compressors, general use water processing systems, purified water processing systems (ion exchange resin, etc.), water distillation systems, dust removal/exhaust systems, or air processing systems shall be installed as needed at medicament factories.The various types of facilities mentioned in Subparagraph 6 through Subparagraph 10 of Paragraph 1 may be installed at medical device factories in accordance with actual needs.
中文原文 藥物製造工廠設廠標準第4條
藥物製造工廠，應具備下列基本條件及共同設備：
一、工廠廠址應選擇環境清潔、空氣新鮮之地帶；其製造、加工及分裝作業場所，應依建築相關法規，並與工廠周圍邊界保持足以避免污染及防火需要之適當距離。
生物藥品或生物技術產品之製造工廠及設施，對病原體之安全防護，不得妨礙公共衛生及安全；廠內之排水溝並應加蓋，防止動物出入散布病原體。
二、廠房之建築應堅固安全，建築物之設計，應能防鼠、防蟲、防塵；室內天花板、牆壁及地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，必要時應採用易於消毒清洗之材料；所有作業場所，均應有良好之照明與通風設備，必要時並應具有適當之溫度、濕度及潔淨度調節設備。
三、廠內作業場所應明確區分（如粉劑製造室、液劑製造室等），兼製環境衛生用藥者，其作業場所，應與其他藥物製造工廠保持相當之距離，必要時並應有隔離之牆壁。
四、設置原料、物料、半製品及最終產品等倉庫。
五、粉塵、廢水、有害廢棄物、有毒容器、有害氣體、生物性成分及其他有害成分或物質之處理設備。
六、工廠應設置符合規定之秤量設備，並定期校正。
七、設置容器洗滌設施。
如係製造眼用液劑、注射劑及生物藥品或生物技術產品者，所用容器之洗滌設施，應特別注意防止污染，並獨立設置。
八、設置工作人員洗手設備及工作衣、帽、口罩、手套、鞋履等之洗滌或消毒滅菌設備。
作業場所外，應視需要設置員工使用之休息室、浴室；製造、加工區域應具備適當之盥洗設施，並與作業場所隔離。
九、設置檢驗部門（化驗室及儀器室）及適當檢驗設備。
但如符合藥物委託製造及檢驗作業準則規定，委託經主管機關認可之單位檢驗，並出具確切證明者，得免設置。
十、對於易燃性或危險性原物料、溶劑、半製品或中間產品及產品之作業場所，應有適當之防護、急救及隔離設施。
藥物製造工廠應視工作上之需要，設置鍋爐、抽水機、真空泵、壓縮機、一般用水處理、純淨水處理（如離子交換樹脂裝置等）及蒸餾水製造、吸塵排氣或空氣處理系統。
第一項第六款至第十款所列各種設備，醫療器材製造工廠得視實際需要設置。
一、工廠廠址應選擇環境清潔、空氣新鮮之地帶；其製造、加工及分裝作業場所，應依建築相關法規，並與工廠周圍邊界保持足以避免污染及防火需要之適當距離。
生物藥品或生物技術產品之製造工廠及設施，對病原體之安全防護，不得妨礙公共衛生及安全；廠內之排水溝並應加蓋，防止動物出入散布病原體。
二、廠房之建築應堅固安全，建築物之設計，應能防鼠、防蟲、防塵；室內天花板、牆壁及地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，必要時應採用易於消毒清洗之材料；所有作業場所，均應有良好之照明與通風設備，必要時並應具有適當之溫度、濕度及潔淨度調節設備。
三、廠內作業場所應明確區分（如粉劑製造室、液劑製造室等），兼製環境衛生用藥者，其作業場所，應與其他藥物製造工廠保持相當之距離，必要時並應有隔離之牆壁。
四、設置原料、物料、半製品及最終產品等倉庫。
五、粉塵、廢水、有害廢棄物、有毒容器、有害氣體、生物性成分及其他有害成分或物質之處理設備。
六、工廠應設置符合規定之秤量設備，並定期校正。
七、設置容器洗滌設施。
如係製造眼用液劑、注射劑及生物藥品或生物技術產品者，所用容器之洗滌設施，應特別注意防止污染，並獨立設置。
八、設置工作人員洗手設備及工作衣、帽、口罩、手套、鞋履等之洗滌或消毒滅菌設備。
作業場所外，應視需要設置員工使用之休息室、浴室；製造、加工區域應具備適當之盥洗設施，並與作業場所隔離。
九、設置檢驗部門（化驗室及儀器室）及適當檢驗設備。
但如符合藥物委託製造及檢驗作業準則規定，委託經主管機關認可之單位檢驗，並出具確切證明者，得免設置。
十、對於易燃性或危險性原物料、溶劑、半製品或中間產品及產品之作業場所，應有適當之防護、急救及隔離設施。
藥物製造工廠應視工作上之需要，設置鍋爐、抽水機、真空泵、壓縮機、一般用水處理、純淨水處理（如離子交換樹脂裝置等）及蒸餾水製造、吸塵排氣或空氣處理系統。
第一項第六款至第十款所列各種設備，醫療器材製造工廠得視實際需要設置。