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发表于 2012-12-24 23:07:51
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药王这么牛叉的蛮？
3.3运输风险评估：
Risk assessment of transportation
3.3.1____要在Docpharm的注册技术文件中原始的稳定性数据的基础上，另外要用上____的________稳定性数据及在____生产的Docpharms产品的原始数据，来建立增温时间和温度上限。
Based on the original stability data provided in the registration dossier by Docpharm a time for enhanced temperatures is set and the maximum temperature is established. Additionally, ____s stability data for ____s ________ is used and also the preliminary data of Docpharms product manufactured at ____.
3.3.2 按照运输公司提供的数据，下列时间是以最糟情况计算出的。
According to the data provided by the transport company, the following time frames are set and calculation is always done as worse case scenario.
____ – Harbour via truck xx hours ____—港口，卡车运，4-6小时
Storage in Shanghai harbour xx days 上海港口的储存时间 xx 天
Storage on ship xx days 船上的储存时间 xx 天
Storage in Hamburg harbour xx days Hamburg港口的储存时间 xx 天
Transport to Rubiepharm/Docpharm via truck xx hours 卡车运到Rubiepharm/Docpharm xx 小时
3.3.4运输季节分为春，夏，秋，冬。xxx地区在这些季节的最高温度为xxoC.
Transport season will be divided in spring, summer, autumn and winter. The highest temperatures during these seasons are expected in the area of xxx and are xxoC.
3.3.5 药品是通过纸箱运输的。这些纸箱是双层箱壁，壁厚xxmm，中间是波状壁，壁厚xxmm ，两层箱壁之间间距为xxmm，放在温度为xxoC的冷冻箱中。这些纸箱是稳定性经检验为xxN的标准箱，质量较牢，一般不会破损。如因包装公司和运输过程中的问题导致纸箱被利物戳破，可以拒收。
The pharmaceuticals are transported in shipping cartons. These cartons are of a sandwich-layer of 2 cartons with xxmm and a corrugated carton of xxmm between. The distance is xxmm. These cartons are transported in cooling containers with a temperature of xxoC. These cartons are standard shipping cartons with a proven stability of xxN. Breakage of the carton is unlikely, because of its sturdiness. Rupture by hitting with sharp objects can be excluded due to the reliability of the packaging company and the transport procedures.
3.3.6风险评估：Risk evaluation of the Chinese Transport company
____上海分公司的简介：
Introduction of Shanghai branch of__________
__________成立于1994年元月，总注册资金为1000万人民币，是中华人民共和国商务部批准的一级国际货物运输代理公司，同时拥有以下资格证书与资质：
相关证书见附件5
__________was established in Jan of 1994 with 10 million RMB registered capital, and is one of the first class enterprises business in transportation approved by ministry of commerce of the People’s Republic of China. The relevant certificates are shown in ATTACHMENT 5:
㈠、 无船承运人资格证书（MOC-NV00762）
NVOCC certificate（MOC-NV00762）
㈡、 国际船舶代理经营资格证书（MOC-NA01300）
International shipment agency business qualification certificate（MOC-NA01300）
㈢、进出口企业资格证书Qualification certificate for import/export enterprise
㈣、水路运输许可证 Transport certificate by sea
在进出口代理业务方面，除了在南京本地的业务发展，在长江沿岸，已经成立的7家分公司，包括：镇江、扬州、南通、盐城、苏州、张家港以及上海。根据提供的数据，本公司认为__________是我公司产品的合适的运输单位。
__________not only does import/export business in Nanjing, but also along Changjiang river. It has 7 branches in Zhenjiang, Yangzhou, Nantong, Yancheng, Suzhou, Zhang jiagang and Shanghai. Based on the data supplied to us, we consider that _____________ is a suitable transport company for our products.
3.4 批号选择Selection of batch
3.4.1作为次此运输验证的是 ________片：规格250mg，批号分别为06001、06002、06003。
________包衣片在仓库中的贮藏条件是防鼠、防虫、防雨淋以及适宜的温湿度，温度为15-25℃。
________ film-coated Tablets: concentration 250mg, batch number: 06001, 06002, 06003 will be used for this transportation validation.
Warehouse conditions for ________ are prevention of mice, insects, rain, under a temperature 15-25℃ and a humidity of。
3.5 运输监控Transport Monitoring
3.5.1温湿度监控
Monitoring temperature and humidity
运输中要用温湿度自动纪录仪来监控温湿度，每二十分钟测一次，温湿度自动纪录仪放在纸箱中抵在纸箱壁上来监控最糟状况。（见附件4）
一个冷冻箱内放一个温湿度自动纪录仪。
During the transport the temperatures are monitored with a datalogger, which takes the temperature and the humidity every 20 minutes. These dataloggers are inside the shipping cartons on the outside layer to monitor the worse case. See ATTACHMENT 4. One datalogger per cooling container is required.
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