利巴韦林工艺验证.docxVIP

长治市三宝生化药业有限公司 编号SBB2.8.5.6 利巴韦林注射液生产工艺 验证方案 长治市三宝生化药业有限公司 方案制订 签名 日期 方案会签 签名 日期 生产技术部签名 日期 验证小组签名 日期 方案批准 质量保证部 日期 目 录 1.概述`````````````````````````````````````````````````````````````````````````````````````````````````````````````````````````````4` 1.1.产品简述``````````````````````````````````````````````````````````````````````````````````````````````````````````````4 1.2.处方及依据``````````````````````````````````````````````````````````````````````````````````````````````````````````4 1.3.生产工艺流``````````````````````````````````````````````````````````````````````````````````````````````````````````5` 2.验证目的````````````````````````````````````````````````````````````````````````````````````````````````````````````````````5 3.验证的范围```````````````````````````````````````````````````````````````````````````````````````````````````````````````6 4.验证各部门职责及组织结构```````````````````````````````````````````````````````````````````````````````6 5.验证准备````````````````````````````````````````````````````````````````````````````````````````````````````````````````````7 6.验证内容及实施``````````````````````````````````````````````````````````````````````````````````````````````````````8` 6.1.洗瓶工序````````````````````````````````````````````````````````````````````````````````````````````````````````````8 6.2.配制工序```````````````````````````````````````````````````````````````````````````````````````````````````````````12 6.3.灌封工序```````````````````````````````````````````````````````````````````````````````````````````````````````````15 6.4.灭菌工序```````````````````````````````````````````````````````````````````````````````````````````````````````````20 6.5.灯检工序````````````````````````````````````````````````````````````````````````````