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```````````````````````````````````````````````````````````````````````````````````````````````````````````24

6.6.包装工序```````````````````````````````````````````````````````````````````````````````````````````````````````````26

6.7.成品检验结果``````````````````````````````````````````````````````````````````````````````````````````````````28

7.偏差分析``````````````````````````````````````````````````````````````````````````````````````````````````````````````````29

8.验证结论``````````````````````````````````````````````````````````````````````````````````````````````````````````````````29

9.附表````````````````````````````````````````````````````````````````````````````````````````````````````````````````````````````29

9.1. 设备一览表及生产能力```````````````````````````````````````````````````````````````````````````````30

9.2.设备性能验证确认及检查情况表```````````````````````````````````````````````````````````````31

9.3参加验证人员培训情况检查表````````````````````````````````````````````````````````````````````32

9.4.厂房与公用设施验证的确认和检查情况表`````````````````````````````````````````````34

9.5.空气净化系统、工艺用水系统验证的确认和检查情况表`````````````````35

9.6.计量器具检查情况表```````````````````````````````````````````````````````````````````````````````````````36

9.7.三批（按四批准备）验证使用的原料、辅料和安瓿

供应商确认及检查情况表`````````````````````````````````````````````````````````````````````````````37

9.8.质量检验系统验证和准备情况表```````````````````````````````````````````````````````````````38

9.9.检验仪器检查情况表``````````````````````````````````````````````````````````````````````````````````````39

9.10检验试剂检查情况表````````````````````````````````````````````````````````````````````````````````````40

9.11质量监控点、监控内容、监控方法、监控频次表`````````````````````````````41

1.概述

1.1.利巴韦林注射液（1ml：100mg）常温状态下是无色的澄明液体，属抗病毒药，用于呼吸道合胞病毒引起的病毒性肺炎与支气管炎。

1.2.利巴韦林注射液组方较为简单，具体工艺处方如下：

处方：

物料名称1ml：100 mg

利巴韦林1000g

氯化钠87g