运输验证方案模版templet of Transport Validation Protocol 07-03-13

______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：机密Confidential

验证方案批准Approval of Validation Plan

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