目录1.概述........................................................................................................................................................21.1设备特性描述.................................................................................................................................21.2使用本设备生产的产品.................................................................................................................22.验证目的..............................................................................................................................................23.职责......................................................................................................................................................33.1验证委员会...................................................................................................................................33.2工程部...........................................................................................................................................33.3质量部...........................................................................................................................................33.4生产部...........................................................................................................................................34.原理......................................................................................................................................................35.验证内容..............................................................................................................................................45.1验证的准备工作...........................................................................................................................45.1.1验证所需文件资料..............................................................................................................45.1.2验证所需的试验条件..........................................................................................................45.2参照检测对象的选择...................................................................................................................45.3确定最差条件参数.......................................................................................................................55.4确定检验方法...............................................................................................................................55.5取样方法的确定...........................................................................................................................55.5.1化学验证取样.........................................................................................................................55.5.2微生物验证取样.....................................................................................................................65.6取样回收率试验.............................................................................................................................65.7确定残余物限量标准...................................................................................................................65.7.1化学样品可接受标准.............................................................................................................65.7.2微生物取样可接受...
