Guidelines of Good Manufacture Practice (GMP)for Veterinary Drugs Manufacturers Article 16
Where the workplace to dispensing, blending, crack, compress, filling and package the antibiotics powder is shared with the common workplaces, there shall be a complete confirmation plan to avoid cross-contamination.There shall be adequate measures made for the products needless of sterilization in their written operating procedures to avoid contamination from the hazardous microbes.There shall be adequate measures made for the products in need of sterilization in their written operating procedures, including the steps to confirm the sterilization validation result to avoid the microbial contamination.
中文原文 動物用藥品優良製造準則第16條
抗生素之粉末，其秤量、混合、粉碎、打錠、充填、分裝等與一般製劑共用作業場所者，應訂立完整確認計畫，避免交叉污染。
毋需滅菌之產品其書面作業程序中應訂立適當之措施，避免有害微生物之污染。
須滅菌之產品其書面作業程序中應訂立適當之措施，包括足以確認滅菌效果之步驟，避免微生物之污染。
毋需滅菌之產品其書面作業程序中應訂立適當之措施，避免有害微生物之污染。
須滅菌之產品其書面作業程序中應訂立適當之措施，包括足以確認滅菌效果之步驟，避免微生物之污染。