新版GMP验证总计划VIP专享VIP免费

验证总计划起草起草人职位签名日期审核审核人职位签名日期总经理质量副总经理质量受权人质量部经理生产部经理供应部经理批准批准人职位签名日期分发QA验证档案（完整的原件）总经理（复印件）生产部经理（复印件）副总经理（复印件）质量部经理（复印件）供应部经理（复印件）目录1.验证方针与本文件的目的.....................................................................................................................41.1验证方针......................................................................................................................................41.2本文件的目的..............................................................................................................................42.简介.........................................................................................................................................................52.1公司基本情况..............................................................................................................................52.2生产区域概述..............................................................................................................................52.3工艺概述......................................................................................................................................62.4产品目录......................................................................................................................................63.目的、范围、要求.................................................................................................................................73.1本验证总计划制定的目的...........................................................................................................73.2验证范围......................................................................................................................................83.3验证基本要求..............................................................................................................................84.验证组织结构及人员职责.....................................................................................................................94.1组织结构图..................................................................................................................................94.2职责............................................................................................................................................105.验证文件...............................................................................................................................................125.1文件范围....................................................................................................................................125.2验证方案....................................................................................................................................135.3验证报告....................................................................................................................................135.4验证记录....................................................................................................................................145.5验证报告....................................................................................................................................145.6验证文件编号........