Pharmaceutical Good Manufacturing Practice Regulations Article 9
Areas at Chinese herbal medicine factories used for the storage of raw materials, product containers, caps, and labeling and packaging materials, and for the manufacture, processing, re-packaging, packaging and storage of products, shall be appropriately sized and located. These areas shall be suitably arranged, with operation areas clearly delineated by production type. Moreover, appropriate work space and levels of insulation and cleanliness shall be established as needed.Levels of cleanliness, as mentioned in the preceding Paragraph, shall be established in accordance with the type of product being manufactured. Operation areas requiring the same level of cleanliness shall be grouped together; buffer zones or entry rooms shall be established between areas with different levels of cleanliness, and different colors or types of work clothes may be used to indicate the cleanliness levels of the various operation areas.No operation area may be used as a passageway by personnel from other operation areas; passageways for people and for the transport of goods shall be separate, and shall not cross.Facilities for the storage of raw materials, product containers, caps, labeling and packaging materials, semi-finished or intermediate products, and products shall be given “pre-inspection,” “approved for use” and “not approved for use” designations; if items are present that need to be kept frozen or toxic, appropriate storage facilities shall be established.Semi-finished or intermediate products shall be stored separately; if they are not stored separately, special care shall be taken to prevent contamination and degradation of quality.Where Chinese herbal medicine factories manufacture environmental sanitation agents, environmental sanitation agent manufacturing, processing and re-packaging areas, as well as raw material storage facilities, shall be separated from pharmaceutical manufacturing, processing and re-packaging areas by a distance of no less than eight meters.Where Chinese herbal medicine factories manufacture pharmaceutical feed additives, the pharmaceutical feed additive operation area shall be independent from other operation areas.Where Chinese herbal medicine factories use their pharmaceutical production facilities to manufacture food products, cosmetics or general goods, care shall be taken to prevent cross-contamination, and validation procedures shall be carried out.
中文原文 藥物優良製造準則第9條
中藥廠儲存原料、產品容器、封蓋、標示材料與包裝材料及製造、加工、分裝、包裝、儲存產品之場所，應有足夠之空間，並設立於適當地點；各場所應作適當排列，並依作業性質明確劃分，確保隔離效果及潔淨度。
前項所稱潔淨度，應依製劑性質分級訂定。
潔淨度相同之作業場所，宜集合成一區域；不同潔淨度之區域間，應設有緩衝空間，並得以不同顏色及工作服區分之。
各作業場所，不得作為其他作業場所人員之通路；物品之搬運與作業人員之通路，不得有共用或交叉情事。
原料、產品容器、封蓋、標示材料、包裝材料、半製品或中間產品及產品之儲存倉庫，應區分為待驗、准用及拒用區；其有劇毒或有冷藏之必要者，應分開存放於適當之場所。
半製品或中間產品，宜隔離儲存，如於未能隔離儲存時，應注意防止交叉污染。
中藥廠兼製環境衛生用藥者，其環境衛生用藥之製造、加工、分裝作業場所及原料倉庫，應與藥品製造、加工、分裝作業場所距離八公尺以上。
中藥廠兼製含藥物飼料添加物者，其飼料添加物之作業場所，應獨立設置。
中藥廠利用原有設備兼製食品、化粧品或一般商品者，應避免交叉污染，並完成確效。
前項所稱潔淨度，應依製劑性質分級訂定。
潔淨度相同之作業場所，宜集合成一區域；不同潔淨度之區域間，應設有緩衝空間，並得以不同顏色及工作服區分之。
各作業場所，不得作為其他作業場所人員之通路；物品之搬運與作業人員之通路，不得有共用或交叉情事。
原料、產品容器、封蓋、標示材料、包裝材料、半製品或中間產品及產品之儲存倉庫，應區分為待驗、准用及拒用區；其有劇毒或有冷藏之必要者，應分開存放於適當之場所。
半製品或中間產品，宜隔離儲存，如於未能隔離儲存時，應注意防止交叉污染。
中藥廠兼製環境衛生用藥者，其環境衛生用藥之製造、加工、分裝作業場所及原料倉庫，應與藥品製造、加工、分裝作業場所距離八公尺以上。
中藥廠兼製含藥物飼料添加物者，其飼料添加物之作業場所，應獨立設置。
中藥廠利用原有設備兼製食品、化粧品或一般商品者，應避免交叉污染，並完成確效。