医药公司保温箱验证方案

4.3每一项验证工作都将包括以下几项
4.3.1 验证的实施人员 4.3.2 验证的对象 4.3.3 验证的目标 4.3.4 验证的测试项目 4.3.5 验证设备及系统描述 4.3.6 测点的布置 4.3.7 时间的控制 4.3.8 数据采集的要求 4.3.9 实施验证的相关基础条件
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文件编号：GDGXDY -VP-003
姓名
部门
岗位
签名
日期
5
文件编号：GDGXDY -VP-003
4 验证方案
4.1概述
保温箱将用于运输小批量、短距离的冷链药品配送。广东盖象大药房有限公司有同一款共五个保温箱， 保温箱设施设备齐全，能满足日常的小批量冷链药品。由于五个保温箱都是同厂家同型号的保温箱，所以 本次验证用其中二个。
验证项目
容积（L） 控制温度（℃）
方案签审
起草
日期
签字
审核 日期
审批 日期
受控状态 受控
签字
签字 发放编号
版本号 001
修订历史
描述 初始批准版本
生效日期
文件编号：GDGXDY -VP-003
目录
1 序言 ····································································································································································· 3 1.1 目的 ························································································································································· 3 1.2 范围 ························································································································································· 3 1.3 术语定义 ················································································································································· 3 1.4 规范性引用文件 ····································································································································· 3
4.1 概述 ························································································································································· 6 4.2 保温箱验证工作的主要实施内容 ········································································································· 6 4.3 每一项验证工作都将包括以下几项 ····································································································· 6 4.4 箱内温度分布特性的测试与分析，分析箱体内温度变化及趋势分析·············································· 7 4.5 蓄冷剂配备使用的条件测试 ················································································································· 8 4.6 温度自动监测设备放置位置确认。 ····································································································· 9 4.7 开箱作业对箱体温度分布及变化的影响···························································································· 10 4.8 高温或低温等极端外部环境条件下的保温效果评估········································································ 11 4.9 运输最长时限验证 ······························································································································· 12 5 验证标准 ··························································································································································· 13 6 附件 ··································································································································································· 13 6.1 保温箱布点图 ······································································································································· 14 6.2 温湿度记录仪校准报告 ······················································································································· 14
1.4规范性引用文件
本验证文件引用下列文件中的部分内容作为相关条款，被引用文件的最新版本适用于本规范 的相关条款。
《药品流通监督管理办法》 《药品经营质量管理规范》 《疫苗流通和预防接种管理条例》 《中华人民共和国药典》
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文件编号：GDGXDY -VP-003
2 责任
根据验证计划，收集必要的项目信息,准备验证方案； 编写验证方案，并执行验证活动； 发现验证工作中的偏差，并做好偏差处理； 编写验证标准； 编写最终的验证汇总报告； 编写最终的验证评价； 编写日常操作过程中需要预防的措施等； 必要时对偏差和纠偏行动进行管理； 对验证方案进行讨论、审核和批准。
No.: GDGXDY -VP-003
受控
广东盖象大药房有限公司 保 温 箱 使 用 前 验 证 方 案
二零一六年七月
文件编号：GDGXDY -VP-003
广东盖象大药房有限公司
文件编号 GDGXDY -VP-003
版本号 001
部门 储运部 质管部
负责人 质管部经理
负责人 质量负责人 实施日期
保温箱使用前验证方案
4.4 箱内温度分布特性的测试与分析，分析箱体内温度变化及趋势分析
验证的实施人员 验证的对象 验证的目标 验证的测试项目
广东盖象大药房有限公司的保温箱 确保保温箱内的温度能满足设计要求，保温箱内的温度是 2~8℃。 通过温度分布特性的测试与分析，分析箱体内温度变化及趋势分析。
验证设备及系统描述
验证设备都经过第三方检测机构：广州计量检测技术研究院的检测，参与验证的 每台验证记录仪都附有合格的校准报告，具有计量标签，并可以用于测试，仪表 的精密度、修正值等符合验证要求，并被确认，测试日期都处于校验有效期内。
验证活动中的关键人员： 部门/职位
职责
质量负责人
负责验证工作的监督、指导、协调与审批。
质管部经理
负责验证文件的审核，组织人员实施验证工作。
质管部
பைடு நூலகம்
负责组织储运等部门共同实施验证工作，做好验证工作的实施。
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文件编号：GDGXDY -VP-003
3 培训
在下表签名的人表示已经阅读和理解了本方案的内容。这一章节必须被将要执行本方案的人签署， 如果需要，可以拷贝本表格
2 责任 ····································································································································································· 4 3 培训 ····································································································································································· 5 4 验证方案 ····························································································································································· 6
文件编号：GDGXDY -VP-003
1 序言
1.1目的
本验证文件为广东盖象大药房有限公司保温箱验证文件，为了验证保温箱的相关设施、设备 及系统能够符合规定的设计标准和要求，并可安全、有效地正常运行和使用，确保冷藏药品在运 输过程中的药品质量。
1.2范围
本验证方案仅适用于广东盖象大药房有限公司本次所验证的保温箱。
1.3术语定义
冷藏药品 指对储存、运输要求 2~8℃温度保存的药品。
冷链 指冷藏药品等温度敏感性药品的储存、流通过程都必须处于规定的温度环境下，以保证
药品质量的特殊供应链管理系统。 验证
指药品批发企业对药品贮藏、运输过程涉及的设施设备等方面的性能状态、效果进行有 文件证明的一系列活动。包括验证方案、验证原始记录、验证报告及实施验证过程中形成的 其它文档或材料。
冷藏运输箱（保温
30
2~8
箱）
4.2保温箱验证工作的主要实施内容
4.2.1 箱内温度分布特性的测试与分析，分析箱体内温度变化及趋势分析； 4.2.2 蓄冷剂配备使用的条件测试； 4.2.3 温度实时监测设备位置放置位置确认； 4.2.4 开箱作业对箱体温度分布及变化的影响； 4.2.5 高温或低温等极端外部环境条件下的保温效果评估； 4.2.6 运输最长时限验证。
测点的布置
每个保温箱的测点数量不少于 5 个。具体布点详见附件布点图。
时间的控制
放置好测试点位后，保温箱预冷一小时后自动启动温度记录仪，记录间隔 2 分钟， 记录持续时间 50 小时。
数据采集要求
在保温箱内一次性同步布点，确保测点数据的同步、有效。
实施验证的相关基础 验证时保温箱已经按照厂家要求标准放置冰排，保温箱为模拟物满载状态。