Guidelines of Good Manufacture Practice (GMP)for Veterinary Drugs Manufacturers Article 15
The raw material quantity used for manufacturing operation shall enable the effective ingredient to remain not less than the label claim.The operation of the raw material dispensing and separation shall be conducted in the specified segregated place with the proper supervision and control.There shall be the detailed written test procedures for the representative sample of each batch of in process product or intermediate product.The quality control department shall execute in process control test on in process products or intermediate products under the existing test procedures and determine the acceptance or rejection concerned in the process. The in process products or intermediate products with the rejection shall be marked and be quarantined and controlled.
中文原文 動物用藥品優良製造準則第15條
製造處方中之原料使用量，應使每批產品之有效成分不低於其標示量。
原料之秤量、細分等操作，應在指定之隔離場所行之，並予適當之監督管制。
每批半製品或中間產品之代表性樣品，應有詳確之書面檢驗管制程序。
製造生產過程中，品質管制部門應依既定檢驗程序執行半製品或中間產品之各項檢驗，並決定准用或拒用。
拒用之半製品或中間產品應予標識並隔離管制。
原料之秤量、細分等操作，應在指定之隔離場所行之，並予適當之監督管制。
每批半製品或中間產品之代表性樣品，應有詳確之書面檢驗管制程序。
製造生產過程中，品質管制部門應依既定檢驗程序執行半製品或中間產品之各項檢驗，並決定准用或拒用。
拒用之半製品或中間產品應予標識並隔離管制。