Establishment Standards for Veterinary Drugs Manufacturers Article 15
There shall be instrument rooms and testing rooms under the provisions listed below with sufficient and adequate test equipments and meters in accordance with the demands of the product test and quality control:1.Instrument room: shall be separated from the test room to prevent gas erosion; there shall be normal temperature and humidity along with sufficient light fittings and measure platforms; and 2.Test room:(1) Facilities: there shall be test platforms, test stands, drug cabinets, exhaust cabinets and facilities for water supply, washers, electric heat, thermostat and dryer, and the containers required ;(2) Instruments, fundamental physical instruments, instruments required by the exclusive test methods and other necessary equipments: weight analyzers, volumetric analyzers, oven , drying ovens, microscopes, and refrigerators;(3) Chemicals: the chemical test reagents , test solutions and standard solutions required by the formulation and reagents required by the tests with sufficient quantity for the common tests; and(4) Experimental animal rooms: shall be applicable to the safety and efficacy tests and may not pollute other facilities.
中文原文 動物用藥品製造廠設廠標準第15條
藥廠應依下列規定設置儀器室及檢驗室，並視產品檢驗與品質管制之需要，設置足夠適當之檢驗設備與儀器：
一、儀器室：應與檢驗室隔離，避免氣體侵蝕，維持正常之溫度與濕度，並有充分之照明設備及測定工作臺。
二、檢驗室：
（一）設備：應設置試驗臺、試驗架、藥品櫃、排氣櫃、供水、洗滌、電熱、恆溫、乾燥等設備，並配置所需之器皿。
（二）儀器、基本理化儀器、專用檢驗方法所需之儀器及其他必要配備：如重量分析儀器、容量分析儀器、恆溫箱、乾燥箱、顯微鏡、電冰箱等。
（三）化學藥品：配置所需之化學試藥、試液、標準液及檢驗所需之藥品，其份量需足維持日常檢驗之用。
（四）實驗動物室：應能供安全、效能試驗之用，且不得污染其他設備。
一、儀器室：應與檢驗室隔離，避免氣體侵蝕，維持正常之溫度與濕度，並有充分之照明設備及測定工作臺。
二、檢驗室：
（一）設備：應設置試驗臺、試驗架、藥品櫃、排氣櫃、供水、洗滌、電熱、恆溫、乾燥等設備，並配置所需之器皿。
（二）儀器、基本理化儀器、專用檢驗方法所需之儀器及其他必要配備：如重量分析儀器、容量分析儀器、恆溫箱、乾燥箱、顯微鏡、電冰箱等。
（三）化學藥品：配置所需之化學試藥、試液、標準液及檢驗所需之藥品，其份量需足維持日常檢驗之用。
（四）實驗動物室：應能供安全、效能試驗之用，且不得污染其他設備。