Guidelines of Good Manufacture Practice (GMP)for Veterinary Drugs Manufacturers Article 31
Any of the specifications, standard operation procedure, sampling plans and test method ordered by the departments of the Manufacturer or the inspection control measures prescribed in the Guidelines and any alteration concerned shall be executed through the examination of the Quality Control Department.The Manufacturer shall comply with the operating regulations prescribed in the Guidelines and record the executive process. If there is any bias,there shall be a record and rational judgment and statements.
中文原文 動物用藥品優良製造準則第31條
藥廠各部門訂立之規格、標準書、取樣計畫、檢驗程序或本準則所規定之檢驗管制措施及其有關之任何變更，均應經品質管制部門審定後方得執行。
藥廠應確實遵行本準則所定各項作業規定，並記錄執行過程，如有偏差發生時，應加以記錄並作合理判定及說明。
藥廠應確實遵行本準則所定各項作業規定，並記錄執行過程，如有偏差發生時，應加以記錄並作合理判定及說明。