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
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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