Pharmaceutical Good Manufacturing Practice Regulations Article 10
All operation areas in Chinese herbal medicine factories shall be equipped with appropriate illumination and ventilation facilities; where necessary, aforesaid areas shall also be equipped with appropriate facilities for the regulation of temperature and humidity.Each production and processing area shall, in accordance with its air purity requirements, be equipped with appropriate air filtration systems, including pre-filters and particulate filters.In areas for the storage of raw materials, products, semi-finished or intermediate products, and areas where products are manufactured, processed, re-packaged or packaged, conditions conducive to the prevention of quality degradation shall be maintained.
中文原文 藥物優良製造準則第10條
中藥廠所有作業場所應有良好之採光與通風設備;必要時,應有適當之溫度、濕度調節設備。
製造、加工區域之空氣供應,應配合其潔淨度,設置包括前濾器及微粒過濾器之適當空氣過濾系統。
原料、產品、半製品或中間產品之儲存場所及產品之製造、加工、分裝、場所,應維持防止品質降低之適當環境條件。
製造、加工區域之空氣供應,應配合其潔淨度,設置包括前濾器及微粒過濾器之適當空氣過濾系統。
原料、產品、半製品或中間產品之儲存場所及產品之製造、加工、分裝、場所,應維持防止品質降低之適當環境條件。