Guidelines of Good Manufacture Practice (GMP)for Veterinary Drugs Manufacturers Article 2
There shall be premises, facilities and equipments in accordance with the Establishment Standards of Veterinary Drugs Manufacturers and the veterinary drugs manufacturer (hereinafter the Manufacturer) shall conform to the circumstances prescribed as follows:1. There shall be the respective clearly written operating procedures for all operations;2. There shall be operators with adequate training able to accurately perform the duties;3. Raw material, product containers, seals, labeling material and packaging material conforming to the existing specifications and storage conditions shall be used;4. All manufacture processes shall meet to the existing operating procedures along with the records of the product manufacture, processing, packaging, storage and distribution recorded and reserved in a clear and easy-to-evaluate manner sufficient to trace the aforesaid matters of each batch to ensure the product quantity and quality to conform to the existing standards;5. There shall be a proper system of product storage and distribution and the establishment of the rapid recall system of sold products.
中文原文 動物用藥品優良製造準則第2條
動物用藥品製造廠（以下簡稱藥廠）應依動物用藥品製造廠設廠標準，設置廠房、設備、設施等，並應具備下列基本事項：
一、所有作業均應分別訂立明確之書面作業程序。
二、應有經適當訓練能正確執行任務之作業人員。
三、應使用合於既定規格及儲存條件之原料、產品容器、封蓋、標示材料與包裝材料。
四、所有製造過程應符合既定之作業程序，並以明確且易評估之方式記載與保存足以追溯每批產品製造、加工、分裝、包裝、儲存及運銷等過程之紀錄，以確保產品數量、品質合於既定規格。
五、產品應有適當之儲存與運銷制度，並建立足以迅速收回已運銷產品之系統。
一、所有作業均應分別訂立明確之書面作業程序。
二、應有經適當訓練能正確執行任務之作業人員。
三、應使用合於既定規格及儲存條件之原料、產品容器、封蓋、標示材料與包裝材料。
四、所有製造過程應符合既定之作業程序，並以明確且易評估之方式記載與保存足以追溯每批產品製造、加工、分裝、包裝、儲存及運銷等過程之紀錄，以確保產品數量、品質合於既定規格。
五、產品應有適當之儲存與運銷制度，並建立足以迅速收回已運銷產品之系統。