温湿度监控系统验证分析报告

1、精心整理江西医药物资有限公司温湿度系统验证报告验证项目：温湿度自动监控系统文件编号：WZYY-04-02验证类型：?使用前验证口停用再次使用前验证专项验证口定期验证目录概述 3二、验 证 方 案 编 制， 变 更 和 批 %准 3三、 验证小组成员与职责 3四、验证目的 3五、验证项产 mF目 4六、偏差和纠偏彳丁为 18七、验证结论及建议 18八、验期 19九、附件 20十、报告确认 20一概述根据药品经营质量管理规范以及国家食品药品监督管理总局关于发布药品经营质量管理规范企业应当对储运温湿度监测系统进行使用前验证，定期验证 及停用时间超过规定时间的验证。二验证方案编制，变更和批准验证小组负

2、责验证方案的编制，验证过程中应该严格按照本方案规定的内容进行， 若因特殊原因确需变更时，应填写验证方案变更申请和批准书，报验证小组批准。 三验证小组成员及职责小组成员姓名职务验证职责组长质量负责人验证文件的批准副组长质管部经理验证文件的审核组员质管员验证文件的起草组员养护员验证测试的执行组员技术支持公司协助验证测试的执行四验证目的通过对温湿度监控系统的布点测试以及各项功能进行逐一确定，确保温湿度监控系统监测点安装位置合理有据，温湿度监控系统各项功能正常运行，符合新版精心整理GSP寸于计算机监控系统的要求五验证项目5.1 布点测试企业仓库平面示意图库房详细信息：库区名称库区向积布点数量麻精库平方

3、米2体外剂阴凉库平方米2阴凉库一平方米3阴凉库二平方米3常温库平方米1 145.2 测点数据示意图布点测试要求：将不少于9个测点尽可能平均分布于仓库，待温度稳定后求取仓库的平均温湿度，与仓库平均温湿度接近的测点作为备选点，排除门，窗，空调，受热墙等因素，尽可能覆盖放药区域的测点作为备选点。5.2.1麻精库库房名称麻精库设定温度0-20分 布 点检 测 项 目记录时恒9:409:459:509:5510:0010:10510:1010:1510:2010:2510:30平均 温湿 度1温 度18.718.318.218.518.418.318.818.318.718.818.418.5湿 度55

4、.156.25657.959.158.457.854.758.357.157.357.12温 度18.618.618.518.518.518.518.818.518.818.518.718.6精心整理湿度60.658.559.457.960.46060.260.259.560.156.359.43温 度18.618.718.718.818.918.818.518.718.71918.818.7湿度606156.55761.861.858.457.661.761.858.659.74温 度18.718.718.518.618.518.818.618.318.518.518.618.6湿度60.3

5、61.260.958.960.860.661.759.760.361.561.160.65温 度18.518.918.618.918.618.718.418.218.318.418.318.5湿度60.954.960.757.755.756.85757.258.36156.257.96温 度18.718.918.618.918.718.918.618.618.818.818.718.7湿度58.855.758.656.860.456.7585754.455.258.257.37温 度18.818.718.618.418.718.91 118.818.718.518.418.518.6湿度57.

6、161.260.362.35762.156.658.459.560.661.359.78温 度18.718.618.618.418.618.518.818.318.818.818.718.6湿度55.960.356.260.256.361.257.559.259.55860.658.69温 度18.818.818.518.718.618.318.718.618.918.518.718.6湿度55.36254.154.260.357.555.254.361.457.361.857.6统计表总平 均温 湿度最高平均温度18.7最低平均温度18.518.6最高平均湿度60.6最低平均湿度57.159

7、.0结论1 .九个点的温湿度均在达标范围内，根据选点要求，根据环境结构因素，检 测区域分布考虑，且尽可能接近室内平均值得出，故选择分布点(5) (9)话合作为有线温湿度采集器摆放的位置,分别用于 监控温度和湿度。2 .根据GSP佥测点安放要求，检测点均放在药品高度的 2/3位置。5.2.2体外剂阴凉库库房名称阴凉库（1）设定温度0-20分布点检 测 项 目记录时间13:0013:0513:1013:1513:2013:2513:3013:3513:4013:4513:50平均 温湿 度1温 度26.826.426.726.826.726.626.826.626.626.426.726.6湿 度

8、57.256.254.857.856.654.9575555.454.754.755.82温 度26.926.926.626.627.126.926.726.626.626.826.926.8湿 度6159.160.859.656.759.458.256.257.160.256.158.63温 度26.626.626.726.326.526.426.926.426.326.626.826.6湿 度55.757.256.857.756.661.36161.161.158.158.258.64温 度26.626.926.92726.826.726.626.826.926.726.826.8湿 度5

9、9.658.960.260.160.759.558.760.459.259.358.759.65温 度2727.126.626.326.526.8272726.326.326.626.7湿 度56.255.35659.554.755.956.360.357595656.96温 度26.81 26.726.826.626.926.426.726.826.526.626.426.7湿 度59.454.755.260.955.856.557.559.457.856.557.857.47温 度26.726.826.526.726.826.826.526.826.726.626.526.7湿 度6062

10、.160.560.857.457.957.660.657.759.66159.68温 度2726.826.626.526.926.926.92726.52726.826.8湿 度55.957.95855.756.25756.856.955.259.257.757.09温27.127.226.626.92727.12727.326.926.926.827.精心整理度0湿度60.3566361.955.961.360.456.958.262.15459.1统计表总平 均温 湿度最高平均温度27.0最低平均温度26.626.8最高平均湿度59.6最低平均湿度55.857.71.九个点的温湿度均在达标

11、范围内，根据选点要求，根据环境结构因素，检 测区域分布考虑，且尽可能接近室内平均值得出，故选择分布点(2) (8)适合作为有线温湿度采集器摆放的位置，分别用结论于监控温度和湿度。2.根据GSP佥测点安放要求，检测点均放在药品高度的2/3位置。5.2.3阴凉库二库房名称阴凉库(2)设定温度分布点检 测 项 目记录时间11:0011:0511:1011:1511:2011:2511:3011:3511:4011:4511:50平均 温湿 度1温 度18.318.718.3:i18.418.218.618.818.518.818.718.618.5湿 度58.457.157.459.25957.25

12、6.255.857.858.15557.42温 度18.818.818.818.818.618.418.618.618.418.718.718.7湿 度55.656.56160.260.156.357.259.460.7595858.53温 度18.818.918.618.818.618.618.818.718.618.918.618.7湿 度58.258.45660.655.661.25858.857.16159.558.64温 度18.718.418.218.618.718.318.518.418.518.418.818.5湿 度5960.759.261.359.258.66260.259

13、.360.660.260.05温 度18.218.618.618.718.518.318.318.318.818.818.818.5湿 度61.35960.561.156.65660.960.756.757.354.958.6精心整理6温 度18.818.618.818.518.718.918.618.518.518.71918.7湿 度58.658.16160.858.954.656.360.554.755.658.658.07温 度18.418.618.618.318.318.718.718.318.418.618.518.5湿 度59.760.76058.356.958.460.561.

14、562.256.560.659.68温 度18.418.518.718.518.418.418.518.618.518.318.418.5湿 度56.456.559.657.759.758.15955.557.254.959.257.69温 度18.818.318.718.718.918.618.818.418.718.818.818.7湿度62.354.454.457.654.759.958.961.76256.159.758.310温 度5.618.718.618.518.718.618.618.718.518.618.528.0湿 度 湿58.35859.159.958.657.857.

15、559.558.459.157.958.611温 度18.518.618.118.618.418.318.918.818.818.63.77.4湿 度58.158.460.260.860.360.35960.961.259.460.659.912温 度18.917.61 17.618617.417.518.417.917.818.916.9湿 度55.15559.154.854.153.155.255.656.154.65955.613温 度18.22.318.12.518.418.118.618.118.618.218.72.0湿度61.559.958.166.765.255.356.466

16、.963.966.958.361.714温 度18.518.618.118.618.418.318.918.818.818.63.77.4湿 度58.158.460.260.860.360.35960.961.259.460.659.915温 度18.917.617.618617.417.518.417.917.818.916.9湿55.15559.154.854.153.155.255.656.154.65955.度6统计表总平 均温 湿度最高平均温度18.7最低平均温度18.518.6最高平均湿度60.0最低平均湿度57.458.7结论1.15个点的温湿度均在达标范围内,根据选点要求和根据

17、环境结构因素， 检测区域分布考虑，且尽可能接近室内平均值得出选择分布点(4) (13) (11)最适合作为有线温湿度采集器摆放的位置， 分别用于监控温度和湿度。2.根据GSP佥测点安放要求，检测点均放在药品高度的 2/3位置。5.2.4阴凉库库房名称阴凉库(3)设定温度0-20分布点检记录时间测 项 目11:0011:0511:1011:1511:2011:2511:3011:3511:4011:4511:50平均 温湿 度温 度18.418.618.618.318.318.818.218.318.218.518.318.41湿 度5956.956.6:i57.354.85657.955.75

18、5.45755.856.6温 度18.618.418.618.518.818.818.718.418.718.618.418.62湿 度55.960.758.357.757.356.355.95759.658.158.157.7温 度18.718.618.618.918.91918.818.318.618.418.818.73湿 度58.959.255.75661.260.861.161.35956.661.359.2温 度18.418.318.218.518.618.818.518.618.718.318.718.54湿 度61.461.958.358.25958.958.258.45958

19、.458.459.1温 度18.718.518.818.418.218.518.918.618.718.718.218.65湿 度58.5576058.1586056.8575555.156.557.56温 度18.818.318.718.318.418.618.718.618.818.918.718.6湿 度55.956.160.8575658.154.858.156.255.457.656.9温 度18.618.818.718.818.61918.918.818.81918.918.87湿 度58.561.75861.258.559.256.457.661.961.960.959.6温 度

20、18.518.618.618.518.618.618.418.718.518.618.718.68湿 度58.359.357.759.157.26058.355.359.559.458.958.5温 度18.818.718.418.918.618.918.718.718.518.618.918.79湿 度59.355.66160.761.758.653.761.757.26354.658.81温 度18.618.318.218.518.918.118.418.418.11818.718.40湿 度59.758.556.355.656.558.856.157.559.456.15857.51温

21、度18.31918.618.218.319.519.218.418.519.43.77.41湿 度58.358.656.2;15756.856.25858.456.357.256.757.21温 度18.51919.119.1618.618.31918.21918.117.52湿 度5858.158.658.559.157.358.159.25858.259.658.41温 度18.72.31 118.32.518.618.718.318.418.718.918.32.03湿 度57.11 J 产58.457.857.357.558.858.959.358.659.458.358.31温 度1

22、8.31918.618.218.319.519.218.418.519.43.77.44湿 度58.358.656.25756.856.25858.456.357.256.757.21温 度18.51919.119.1618.618.31918.21918.117.55湿 度5858.158.658.559.157.358.159.25858.259.658.4统计表总平 均温 湿度最高平均温度18.8最低平均温度18.418.6最高平均湿度59.6最低平均湿度56.658.315个点的温湿度均在五 测区域分， 选择分布点(4) (9)t标范围内，根据选点要求和根据环境结构因素， 行考虑，且尽

23、可能接近室内平均值得出(12)最适合作为有线温湿度采集器摆放的位置,检结论分别用于监控温度和湿度。2.根据GSP佥测点安放要求，检测点均放在药品高度的 2/3位置。5.2.5常温库库房名称常温库(1)设定温度0-20分布点检 测 项 目记录时间11:0011:0511:1011:1511:2011:2511:3011:3511:4011:4511:50平均 温湿 度温26.度:26.526.526.82726.526.826.626.826.926.726.77湿1 157.1度;55.858.457.756.857.557.858.456.75956.954.83温26.度26.726.72

24、6.62726.426.826.926.626.626.826.97湿;59.2度6056.65660.360.158.560.361.26060.758.63温26.度26.826.526.426.626.826.526.826.826.826.426.66湿159.3度60.159.958.957.761.359.860.760.357.358.361.86温26.度;26.626.427.126.826.626.426.426.827.126.326.91 7湿1J60.4度61.758.360.158.858.859.559.460.961.459.961.50温26.度26.8272

25、6.926.726.626.726.927.126.726.926.88湿58.5度56.459.155.359.859.760.855.957.959.660.461.48温26.度26.326.626.526.626.626.526.526.426.626.726.45湿57.6度;57.755.254.856.956.659.160.455.957.55660.61 3温26.7度26.426.426.526.626.726.626.426.726.626.626.76湿度61.158.160.758.656.861.261.862.15758.157.459.48温 度26.626.7

26、26.526.826.726.426.726.726.826.726.426.6湿度5560.857.256.254.956.556.656.156.456.460.156.99温 度26.926.627.226.526.927.32726.526.426.62726.8湿度56.45857.354.659.660.854.961.16258.562.358.710温 度26.326.626.526.626.626.526.526.426.626.726.426.5湿度57.755.254.856.956.659.160.455.957.55660.657.311温 度26.426.426.5

27、26.626.726.626.426.726.626.626.726.6湿度61.158.160.758.656.861.261.862.15758.157.459.412温 度26.626.726.526.826.726.426.726.726.826.726.426.6湿度5560.857.2;156.254.956.556.656.156.456.460.156.913温 度26.926.627.226.526.927.32726.526.426.62726.8湿度56.45857.354.659.660.854.961.16258.562.358.714温 度26.426.41 126

28、.526.626.726.626.426.726.626.626.726.6湿度61.11产58.160.758.656.861.261.862.15758.157.459.415温 度26.626.726.526.826.726.426.726.726.826.726.426.6湿度5560.857.256.254.956.556.656.156.456.460.156.9统计表总平 均温 湿度最高平均温度26.8最低平均温度26.526.7最高平均湿度60.0最低平均湿度56.958.5结论15个点的温湿度均在达标范围内，根据选点要求和根据环境结构因素，检 测区域分布考虑，且尽可能接近室内

29、平均值得出选择分布点(3) (4) (10) (12)最适合彳为有线温湿度米集器摆放的 位置，分别用于监控温度和湿度。2.根据GSP佥测点安放要求，检测点均放在药品高度的 2/3位置。5.2温湿度监控硬件设备与系统情况检查人：日期：复核人：日期：5.3温湿度监控系统各分项设备/材料名称型号品牌备注温湿度变送器(硬件)有线内置温湿度变送器WS-TH20SWASON米用原装进口温度传感器，精度 高，稳定性好，采样速度快，能 准确采集并且记录数据。测温范围:-2060 C测湿范围：0100%RH温度精度： 0.2 C湿度精度： 1.0%RH经国家技术监督部门检定合格， 能提供相关检定合格证书。管理主

30、机和报警系统(硬件)管理主机+短信+声 光报警器模块(含 UPS)1 WASONWASON管理主机用于温湿度监控系统的 线路连接供电和数据的收集和下 载。当监测库区温湿度超限或者系统 供电中断时，触发声光报警，同 时通过短信形式发送报警信息给 负责人。11 11 X - 1J .J温湿度自动监控管理软件 1温湿度自动监控管理软件Kingbos广州金博信息技术有限公司动态实时显示监测数据。计算机 可选配工业监控主机，长时间运行稳定，运行 WINXP即可。若仪 器设置的温湿度上下限超标，仪 器自动报警，并且可以外置报警 模块报警。用户可以直接在电脑 上查看相应监测点的温湿度值， 以及超标报警。能运

31、行于局域网 内任意计算机，可以查询任意记 录仪历史数据，自动生成报表曲 线。即使终端电脑关闭或者断 电，仪器可以自动记录存储数 据，整个系统仍然能正常运行。当电脑开启时，可以查询到电脑 关闭或者断电时的数据。项功能的确认检查名称检查项目检查要求符合与否库房温湿 度传感器 采集、传 送、记录 数据确认每个传感器是否能正常 采集检查每个设备供电是否 正常，温湿度数据显示 是否正常?是口否传送、记录数据是否正 常温湿度在各库区的要求 的温湿度范围内，温湿 度监控系统是否能30分钟记录一次温湿度情况，当发生温湿度异常 时，系统是否能2分钟1 记录一次?是口否冷藏车双 温度传感 器采集、 传送、记 录数

32、据确 认每个传感器是否能正常 采集检查每个设备供电是否 正常，温湿度数据显示 是否正常?是口否传送、记录数据是否正 常温度在冷臧车要求的温 湿度范围内，温度监控 系统是否能至少5分钟 记录一次温度情况，当 发生温湿度异常时，系 统是否能2分钟记录一 次?是口否1 ;z报警功能 的确认就地报警当某台温湿度传感器， 温湿度超标时，是否会 就地发出锋鸣报警?是口否声光报报警当有温湿度传感器，温 湿度超标时或是断电， 系统是否会声光报警?是口否短信报警当有温湿度传感器，温 湿度超标时或是断电， 系统是否会向至少3个 指定人员发出报警短 信。短信内容是否有反 映温湿度超标的情况或是断电的情况。?是口否监测设备温度的测量范围以及准与经第二方机构校准的?是口否的测量范 围和准确 度确认确度确认设备比对，测量每台温 湿度传感器在测量范围 为0c40c之间，温度 的误差是否符合规定的“误差为士 0.5 C” ；在 测量范围