方案编号：版本号：XXXXXX工艺验证方案类别验证管理工艺验证方案制定人制定日期审核人审核日期批准人批准日期颁发部门生效日期复印数XXXXXXXXXXXXXXXXXXXXXXXX第2页共36页目录一、概述...............................................................................................................................................................11.1验证产品基本信息....................................................................................................................................11.2背景............................................................................................................................................................11.3目的............................................................................................................................................................11.4验证小组人员及职责................................................................................................................................11.5范围............................................................................................................................................................11.6关键工艺参数与变量................................................................................................................................21.7质量控制标准............................................................................................................................................2二、工艺介绍.......................................................................................................................................................32.1产品处方....................................................................................................................................................32.1.1下表列出0.1g规格XXXXXX的处方..................................................................................................32.1.2原材料合格供户清单.........................................................................................................................32.2工艺规程....................................................................................................................................................42.3工艺流程图................................................................................................................................................52.4生产设备和设施........................................................................................................................................62.4.1JD200-3G电子天平............................................................................................................................62.4.2JM3XXX1电子称.................................................................................................................................62.4.3SYH-20型三维混合机........................................................................................................................62.4.4ZP129型旋转压片机..........................................................................................................................62.4.578X-2片剂四用测定仪.......................................................................................................................62.4.6GBB-60B型高效包衣机..............................................................................
