T-中德合资公司运输验证方案模版带风险评估templet-of-Transport-Validation-Protocol.doc

Business Consulting Co., Ltd
验证文件(VLD)
验证项目
__________运输验证确认方案
编 号
YZ-000-00
验证部门
质量保证部、运输公司、
页 码
第 16 页 共 16页

______药业股份有限公司
______PHARMACEUTICAL CO., LTD.

________250mg包衣片运输验证方案
Transport validation protocol of ________ 250mg film-coated Tablets

验证项目编号 YZ-000-00
Validation Project Code

2007年 月

密 级： Confidential

验证方案批准
Approval of Validation Plan

方案审核audited by
签名Signature
日期Date
库管科科长
Warehouse Director

生产技术部经理：
Production Manager

质量保证部经理：
QA Manager

方案批准approved by
签名Signature
日期Date
药品制造公司总经理：
General manager

方案最终批准finally approved by
签名Signature
日期Date
德方项目负责人：
German QA Manager

目 录
Contents

1、 目的 Purpose
2、 职责 Scope
3、 引言 Introduction
3.1、概述 Summary
3.2、验证小组成员及验证时间
Members of Validation Team and Validation Time
3.3、根据产品的贮藏条件对运输进行风险评估
Risk evaluation of transportation under the storage condition
3.4、运输过程的确认Confirmation during shipping
4、 验证实施 Validation actualization
5、 验证结果分析和评价
Analysis and estimate of validation result
6、 验证结果评定与结论
Assessment and conclusion of validation result
7、 附件 Attachment

1、 目的：Purpose
为了评价________片运输过程中可能影响产品质量的各种环境变化因素，对其整个运输过程进行验证。证明运输过程不会影响产品的质量。
验证过程应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及批准书（附件2），报验证领导小组批准。
This validation will assess the various changeable environment factors which could influence product quality. This validation will cover the whole transport procedure, and prove that the current transport can ensure the quality of product when it arrives in Germany.
The validation procedure should be implemented according to this protocol. If it has to be changed because of a special reason, an application of change in transport validation protocol should be filled in (ATTACHMENT 2), and be approved by validation leader team.
2、职责 Responsibility
2.1本公司 Our company
2.1.1负责验证方案的起草审批。
Responsible to draft and approve validation plan
2.1.2负责验证的人员协调工作，以保证本验证方案规定项目的顺利实施。
Responsible to appoint the members of the validation team
2.1.3负责验证数据及结果的审核。
Responsible to audit the data and result of validation
2.1.4负责验证报告的起草审批。
Responsible to draft and authorize validation report
2.1.5 负责建立分析数据，运输前在中国的产品放行。
Responsible to create the first analytical data set in China for the release of products for transport.
2.2运输公司 Transport company
2.3.1负责运输过程环境中的建议。
Responsible to advise on the environmental surroundings during the transport of the products
2.3.2负责在产品运输过程中控制规定的温湿度。
Responsible to control the environment during transportation at the required temperature and humidity
2.3德方公司 German company
2.3.1负责验证方案、报告的批准。
Responsible to authorize validation plan and report
2.3.2负责产品到德方公司后的质量检测及数据收集并反馈到_____________药业股份有限公司，负责在德国的产品放行。
Responsible to perform the analytical tests for the product release in Germany and exchange the laboratory data with our company
3、引言Introduction
3.1概述：Summary
3.2验证小组成员及验证时间
Members of Validation Team and Validation Time
3.2.1验证小组成员：xxxx（职务），xxxx（职务），Dr. Kluge (Rubiepharm 的QA 经理)，xxxx（运输公司的xxx）。
Members of Validation Team: xxxx (position), xxxx (position), Dr. Kluge (QA manager of Rubiepharm), xxxx (of transport company)
3.2.2验证时间： 年 月 日至 年 月 日验证结束，于 年 月 日完成验证报告。
Validation Time: From to , finish the validation.
On finish the validation report.
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记录仪来监控温湿度，每二十分钟测一次，温湿度自动记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.
3.5.2 运输监控Monitoring Transport
在和运输公司的的合作中，需要交接单，见附件1。
In co-operation with the transport company, the following “hand-over” sheet has been developed. See ATTACHMENT 1.
3.5 Transport Procedures现在我们的运输是委托__________上海分公司、__________国际货运代理有限公司进行海运，产品是放在金属密闭的冷冻箱中（型号???），所以我们可以确认防鼠、防虫、防雨淋是没有问题的，主要风险是运输过程中温度（15-25℃）对产品质量的影响，所以在运输过程中我们主要对冷冻箱温度用温湿度自动纪录仪进行监控。
Now we use Shanghai branch of__________, __________Transportation Co, Ltd to transport our goods by sea, the products are put in a metal airtight cooling container (type???). So there’s no risk of contamination with mice, insects or rain. The temperature will be set at 15-25℃during shipping, and we will supervised via dataloggers.
3.6 运输步骤
Steps to commence transportation
3.6.1　运输代理公司：__________上海分公司、_________国际货运代理有限公司。
Transport company ：Shanghai branch of__________, __________Transportation co,Ltd
3.6.1.2__________上海分公司的运输流程：
Transport procedure of Shanghai branch of__________
㈠、 ____公司将出口拖单传给运输公司
____ gives the export certificate to the transport company.
㈡、 运输公司与船公司确认冷冻箱舱位、箱子情况及价格
The transport company confirms the location and information of cooling container and the price with shipping company.
㈢、 船公司确认后放船名航次提单号给运输公司。
After confirmation, the shipping company gives the loading number to transport company.
㈣、运输公司安排车队来领取冷冻箱。他们凭船名航次提单号到船公司现场。
The transport company arranges trucks to transport the cooling container to ____. They also bring the documents with the name, number of the ship and loading number from the shipping company.
㈤、现场实验冷冻箱制冷状况，完好后提箱发车去____。
After testing cooling containers by themselves, they drive the cooling containers to ____.
㈥、冷冻箱车带着交接单到____公司后，____QA经理先确认冷冻箱制冷设备温度达到____公司要求后，开始装箱密封。冷冻箱的温度验证按照SOP XXXXX.做。
When the trucks of transport company arrive with the cooling containers plus the handover sheet in hand at ____. The QA of ____ validates the temperature of the cooling containers. Then the containers are loaded with the above identified products and sealed. The validation of the temperature of the cooling container is done according to SOP XXXXX.
㈦、冷冻箱到达港区门口，港区人员检查冷冻箱制冷情况良好后，箱子进入
港区冷冻箱堆放区，继续制冷。
Storeman in the harbor check the temperature of the cooling container and put it into the appropriate area for cooling containers.
㈧、冷冻箱装至船上制定可制冷区，于船上全程制冷出运至目的港。
During shipment the cooling container is stored in the designated area of the ship.
3.7到达 Docpharms 的仓库的步骤
Arrival Procedures at Docpharms warehouse
冷冻箱到达仓库时，Docpharm 将发出确认信。还要把温湿度记录仪和交接单原件（包括进入Docpharm仓库的最后一份）寄到____进行确认。
Docpharm will send a confirmation that the container has arrived at the warehouse. The datalogger and the original “hand-over sheet” (including the last signature of the warehouse operator of Docpharm) are sent to ____ for confirmation.
另外Docpharm要把在德国实验室做的分析数据寄到____去确认运输对药品的影响。
Additional Docpharm will send the analytical data of the German laboratory to ____ to confirm the influence of the transport.

4、验证实施Validation actualization
根据验证方案对运输过程进行验证，为保证验证的可靠性，本验证共进行3次。
The transport of pharmaceuticals between ____ and Docpharm is validated according to this validation protocol. Any changes of the procedures have to be authorised by the members of the Validation team. The transport validation will be done a minimum of 3 times.
5、验证结果分析和评价
Analysis and estimate of validation result
质保部负责根据验证情况，收集各项验证、试验结果记录，根据验证、试验结果起草验证报告。
QA department is responsible of collecting all validation and testing result and draft validation report according to the results.
6、验证结果评定与结论
Assessment and conclusion of validation result
本公司负责对验证结果进行综合评审，作出验证结论，发放验证证书（附件3）
Our company is responsible to prepare the assessment and conclusion of validation results, issued as validation certificate (ATTACHMENT 3). The certificate has to be countersigned by the QA of Docpharm.
7、附件Attachment

附件1. Attachment 1
Transport hand-over sheet
运输交接单
Date
日期
Time
时间
Name of transferring company
运输公司
Name of transferring Person
运输人姓名
Signature of transferring person
运输人签名
Name of receiving company
接收公司名称
Name of receiving person
接收人姓名
Signature of Receiving Person
接收人签名
Temperature /humidity
温度/湿度
Remarks
备注

附件2. Attachment 2
验证方案修改申请及批准书
Application of changes in transport validation protocol
验证方案名称
Name of transport validation protocol

修改内容
Changed content

修改原因及依据
Reason and gist

修改后方案
Changed protocol

起草人　　　　　部门经理　　　　　　年 　　月 　 日
drafted by Department Manager Date
验证领导小组审批
Approved by validation leader team

验证领导小组负责人Principal of validation leader team
Date 年 月 日
德方项目负责人最终审批
Finally authorize report
By German

德方项目负责人Principal of German Project
Date 年 月 日

附件3 Attachment3
验证证书Validation Certificate

验证证书
Validation Certificate

方案名称：
Name of protocol

上述运输过程已按验证方案进行验证，各项验证结果符合标准要求，批准按该运输过程进行。
The transport procedure is implemented according to this validation protocol and all results comply with standard ,so this transport procedure is approved .

验证报告名称：
Validation report

验证完成日期：
Finished date of validation

验证领导小组validation leader team
Date 年 月 日

附件4 Attachment4
运输验证记录
Record of transport validation
温度、湿度
Temperature,humidity
时间 Time
温度
Temperature
温度、湿度
Temperature,humidity
时间 Time
温度
Temperature
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