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.docVIP

______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 目的 Purpose 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 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 rep