Guidelines of Good Manufacture Practice (GMP)for Veterinary Drugs Manufacturers Article 13
The Manufacturer shall set up the written operating procedures of the process control which shall be approved by the Quality Control Department to insure the product property, contents, quality and purity.The bias between the actual control operation and the written procedures shall be recorded along with the rational judgment and illustration.
中文原文 動物用藥品優良製造準則第13條
藥廠應訂立製程管制之書面作業程序，並經品質管制部門核定，確保產品之特性、含量、品質及純度。
實際管制作業與書面程序有偏差者，應加以記錄並作合理判定及說明。
實際管制作業與書面程序有偏差者，應加以記錄並作合理判定及說明。