Guidelines of Good Manufacture Practice (GMP)for Veterinary Drugs Manufacturers Article 11
The raw materials and product containers or seals which conform to meet the specifications through the test shall be release, whereas those which fail to meet the specifications shall be rejection.The raw materials and product containers or seals with the acceptance shall be used under the principle “the first release first use”. Those under the long-term storage, or exposed to the air, high temperature or other unfavorable conditions shall be retested.The raw materials and product containers or seals with the rejection shall be marked and be quarantined and controlled prior to proper treatment.
中文原文 動物用藥品優良製造準則第11條
原料、產品容器或封蓋經檢驗合於其書面規格者,應予准用;不合格者應予拒用。
經准用之原料、產品容器或封蓋,以先准先用為原則。
如經長期儲存,或暴露於空氣、高溫或其他不利條件下,應予重行檢驗。
經拒用之原料、產品容器或封蓋,應予標示,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,以先准先用為原則。
如經長期儲存,或暴露於空氣、高溫或其他不利條件下,應予重行檢驗。
經拒用之原料、產品容器或封蓋,應予標示,並於作適當處理前隔離管制。