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.验证预备
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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
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9.4.厂房与公用设施验证的确认和检查情况表
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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（按四批预备）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预备情况表```````````````````````````````````````````````````````````````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
药用炭 20g
共制成 10000支处方依据：
中国药典2010年版二部
批准文号：国药准字H19999232
批准机构：国家药品监督治理局1.3.生产工艺流程：
该产品从2010年批准生产以来，处方和生产工艺没有发生变更，产品质量差不多稳定，没有质量事故发生。
2012年公司搬迁和GMP改造，厂房设施发生了变更，精滤、稀配制、灌封等工序的生产环境由原来万级洁净区变更为现在的A级洁净区，生产操作人员在原来知识的基础上
按照新版GMP进行再次培训，不管从操作技术依旧生产理念都有专门大的提高。
2.验证目的
依照2010版GMP要求，通过对利巴韦林注射液(1ml：100mg)产品工
艺的验证，推断生产系统各要素和生产过程中可能阻碍产品质量的各种工艺变化因素，对其整个生产过程进行验证，以保证在正常的生产条件下，生产出合格、均一、稳定的利巴韦林注射液。
同时确定岗位SOP修订的合理性，分析阻碍产品质量的关键因素，纠正偏差，建立生产全过程的运行标准和监控标准，确保产品质量安全有效。
3.验证的范围
本次验证是在该产品正常生产所需的厂房设施、生产设备、仪器仪表、检验设施设备及检验方法均通过了验证和校验、参与验证的相关人员都通过培训的前提下，按照批准的生产工艺规程和岗位SOP进行严格监控下的正常生产；所有记录真实、准确；所有抽样检验严格按照批准的规
程进行。
当上述条件之一改变时，应重新验证。
4.验证各部门职责及组织机构
4.1验证组
4.1.1负责验证方案的审批。
4.1.2负责验证的协调工作，以保证本验证方案规定项目顺利实施。
4.1.3负责验证数据及结果的审核。