Pharmaceutical Good Manufacturing Practice Regulations Article 29
Where raw materials, product containers or caps are tested and found to be in compliance with documented specifications, Chinese herbal medicine factories may approve them for use; where aforesaid items are not in compliance, they shall not be approved for use.Raw materials, product containers or caps that are approved for use shall be used in the order of approval. However, where aforesaid items have been stored for long periods, exposed to the air or high temperatures, or subjected to other detrimental conditions, retesting shall be carried out.Raw materials, product containers or caps that are not approved for use shall be labeled to this effect, and kept isolated prior to their proper disposal.
中文原文 藥物優良製造準則第29條
中藥廠對於原料、產品容器或封蓋經檢驗合於其書面規格者,准予使用;不合格者,應予拒用。
經准用之原料、產品容器或封蓋,應以先准先用為原則。
如經長期儲存,或暴露於空氣、高溫或有其他不利條件者,應予重行檢驗。
經拒用之原料、產品容器或封蓋,應予標識,並於作適當處理前隔離管制。
經准用之原料、產品容器或封蓋,應以先准先用為原則。
如經長期儲存,或暴露於空氣、高溫或有其他不利條件者,應予重行檢驗。
經拒用之原料、產品容器或封蓋,應予標識,並於作適當處理前隔離管制。