2012年-丹参川芎嗪注射液工艺规程(新设备).docVIP

STP-GG-SZ-009-00 丹参川芎嗪注射液生产工艺规程 Page PAGE 17 of NUMPAGES 24 技 术 标 准 文件名称 丹参川芎嗪注射液生产工艺规程 制 订 人 制订日期 年 月 日 审 核 人 审核日期 年 月 日 批 准 人 批准日期 年 月 日 颁发部门 质量部 生效日期 年 月 日 分发部门 总经理[ ]份 质量部[ ]份 质检室[ ]份 物控部[ ]份 生产部[ ]份 技术部[ ]份 注册部[ ]份 工程部[ ]份 结算部[ ]份 行政部[ ]份 水针车间[ ]份 输液车间[ ]份 冻干车间[ ]份 生化提取车间[ ]份 动物房[ ]份 仓库[ ]份 中药提取车间[ ]份 原料药车间[ ]份 变更内容 修订号 修订原因与内容 执行日期 目 录 1 主题内容 ····································································································3 2 适用范围······································································································3 3 职责 ·········································································································3 4 内容 ·········································································································3 4.1 产品名称、剂型、规格、产品代码····································································3 4.2 产品批准文号 ······························································································3 4.3 标准来源和处方·····························································································3 4.4 产品概述· ···································································································4 4.5 工艺流程图···································································································5 4.6 操作过程及工艺条件 · ·················································································6 4.7 工艺卫生……………………………………………………………………………………14 4.8 原辅料、中间产品、成品、包装材料的质量标准和检验方法…………………………15 4.9 质量监控要点及标准………………………………………………………………………16 4.10 物料平衡计算………………………………………………………………………………16 4.11 收率计算·······································································································16 4.12 主要设备一览表……………………………………………………………………………17 4.13 安全生产及劳动保护………………………………………………………………………17 4.14 劳动组织与岗位定员………………………………………………………………………1