Establishment Standards for Veterinary Drugs Manufacturers Article 17
As for the ophthalmic preparations, injections, biomedicines or biotechnical products, there may be places, facilities and equipments for aerobic count or aseptic tests along with the required culture media and compared strains in accordance with the test demands. As for the antibiotics, hormone, biomedicines or biotechnical products, there may be places, facilities and equipments for safety tests and bioassay along with the breeding and observing rooms for the required animals. The establishment conditions of the aseptic room and anatomic room shall meet the demands of the tasks. The microbial strains, culture media and animals required by the bioassay shall be properly allocated and maintained.
中文原文 動物用藥品製造廠設廠標準第17條
眼用製劑、注射劑、生物藥品或生物技術產品等，得視檢驗需要，設置生菌數試驗、無菌試驗等之場所、設施及設備，並配置所需之培養基及對照菌種。
抗生素、荷爾蒙、生物藥品或生物技術產品等得視檢驗需要，設置安全試驗及生物檢定之場所、設施或設備，並配置所需之動物及其飼養觀察場所。
無菌室、解剖室等之設置條件應能配合工作之需要，生物檢定所需微生物菌種、培養基、動物等應妥為配置及維護。
抗生素、荷爾蒙、生物藥品或生物技術產品等得視檢驗需要，設置安全試驗及生物檢定之場所、設施或設備，並配置所需之動物及其飼養觀察場所。
無菌室、解剖室等之設置條件應能配合工作之需要，生物檢定所需微生物菌種、培養基、動物等應妥為配置及維護。