Pharmaceutical Good Manufacturing Practice Regulations Article 11
For Chinese herbal medicine factory production areas involving hazardous or flammable raw materials, solvents, semi-finished or intermediate products, or products, appropriate protective, first-aid and segregation facilities shall be established.Facilities used in the manufacturing, processing and re-packaging process shall be airtight from start to finish; where facilities are not airtight and dust or hazardous gases are produced, local exhaust ventilation systems and negative pressure procedures shall be established.Lighting, switches, sockets, motors and other electric devices for operation areas that produce dust, where organic solvents are used, or where hazardous substances are present, shall, as needed, be explosion-proof, airtight, or isolated from operation area.Boilers, pressure vessels, cranes and other types of dangerous equipments and facilities shall be inspected and approved in accordance with relevant regulations before use.
中文原文 藥物優良製造準則第11條
中藥廠對於具有危險性或易燃性之原物料、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。
製造、加工、分裝作業過程中之設施，應由進料口至出料口，採一貫密閉式作業為原則；其未採一貫密閉式作業者，如有粉塵或有害氣體產生，應設置局部排氣裝置及負壓操作。
產生粉塵、使用有機溶劑或涉及危險性物品之作業場所，其有關照明、開關、插座、馬達及其他各項電氣設施，應視工作需要，採用防爆型、全密閉型或與作業場所隔離。
鍋爐、壓力容器、起重機及其他具危險性之設施，應依有關法令規定經檢查合格者，始得使用。
製造、加工、分裝作業過程中之設施，應由進料口至出料口，採一貫密閉式作業為原則；其未採一貫密閉式作業者，如有粉塵或有害氣體產生，應設置局部排氣裝置及負壓操作。
產生粉塵、使用有機溶劑或涉及危險性物品之作業場所，其有關照明、開關、插座、馬達及其他各項電氣設施，應視工作需要，採用防爆型、全密閉型或與作業場所隔離。
鍋爐、壓力容器、起重機及其他具危險性之設施，應依有關法令規定經檢查合格者，始得使用。