欧盟药品GDP及药品冷链技术 全.pptVIP

? Premises and Equipment Contd 库房与设备 ( 续 ) – Temperature excursions in cold room not investigated 冷库温度超出范围，没做调查 – Data loggers not calibrated within operating range 没有对数据自动记录仪在其运行范围内对校准 MDA Drugs MDA 药品 F Inadequate control. Poor security 没有足够控制，安全性不良 GDP Deficiencies – General 执行流通规范常中的见缺陷 F Discrepancies not adequately investigated 对差异情况没有适当调查 u Dangerous storage practices 储存做法危险： F Rat poison stored over Baby Food Products 将毒鼠药储存在婴儿食品上 F Organophosphorus compds stored over open 将有机磷化合物存放在上面 ? containers packaging components 容器包装成分。 GDP Deficiencies – Gener