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1、上海金冀商务咨询有限公司, Shanghai Jinji 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 15 页 共 15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-000-00Validation Project Code2007年 月密 级： 机 密Confidential验证
2、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Contents1、 目的 Purpose 2、 职责 Scope3、 引言 Int
3、roduction3.1、概述 Summary3.2、验证小组成员及验证时间Members of Validation Team and Validation Time3.3、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 shipping4、 验证实施 Validation actualization5、 验证结果分析和评价Analysis and estimate of validation result6、 验证结果
4、评定与结论 Assessment and conclusion of validation result7、 附件 Attachment1、 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 produ
5、ct 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
6、application of change in transport validation protocol should be filled in (ATTACHMENT 2), and be approved by validation leader team.2、职责 Responsibility2.1本公司 Our company2.1.1负责验证方案的起草审批。Responsible to draft and approve validation plan2.1.2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 mem
7、bers 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 validation2.1.4负责验证报告的起草审批。Responsible to draft and authorize validation report2.1.5 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
8、.2运输公司 Transport company2.3.1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 humidity2.3德方公司 German company2.3.1负责验证方案、报告的批准。
9、Responsible to authorize validation plan and report2.3.2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Introduction3.1概述：Summary3.2验证小组成员及验证时间Members of Validation Team
10、and Validation Time3.2.1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
11、 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
12、 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 calculat
13、ion 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
14、 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x
15、xN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 stan
