Table of Contents
目录表
1 Roles and Responsibilities related to validation
与验证相关的1个角色和职责
2 Introduction
2引言
3 Prepare for validation
3准备验证
3.1 Risk evaluation
3.1风险评估
3.2 Requirements
3.2要求
3.3 Validation strategy and plan
3.3验证策略和计划
3.4 Personnel training
3.4人才培养
4 Establish validated state
4建立验证状态
4.1 Configuration management
4.1配置管理
4.2 Test & qualification
4.2测试与鉴定
4.2.1 Measuring equipment – test and qualification
4.2.1测量设备试验和鉴定
4.3 Validation incidents and incidents
4.3验证事件和事件
4.4 Documentation of the establishment of the Validated State
4.4建立验证状态的文件
5 Maintain validated state
5保持验证状态
5.1 Change control
5.1变更控制
5.2 Re-validation / Re- qualification
5.2重新验证/重新鉴定
5.3 Measuring equipment – maintenance
5.3测量设备-维修
5.4 Preventive maintenance
5.4预防性维修
6 Discontinuation
6中止
7 References
参考文献7篇
8 Definitions, abbreviations and terms
8定义、缩略语和术语
Appendix 1: References to regulatory requirements related to
附录1：有关法规要求的参考文献
Validation
验证
9 Change log
9变更日志
1、Roles and Responsibilities related to validation 与验证相关的角色和职责
Generic roles related to the validation process and to the application of validation are listed below. 下面列出了与验证过程和验证应用相关的通用角色。
Explicit roles and responsibilities are detailed in the specific validation procedures [1][2][3][4][5].
明确的角色和职责在具体的验证程序[1 ]〔2〕〔3〕〔4〕〔5〕中详述。
a.Line management in GxP areas. GXP区域的线路管理。
职责：Overall responsibility for the validated state of products, processes and equipment / systems in their own area according to relevant procedures and instructions. Appoint and allocate resources to the roles described in the validation process and ensure they are trained
根据相关程序和指示全面负责产品、工艺和设备/系统的有效状态。为验证过程中描述的角色分配和分配资源并确保其被培训
b.Validation responsible person 验证负责人
Prepare, establish, maintain and/or discontinue the validated state
准备、建立、维护和/或停止验证状态
c. Project manager of projects which include validation activities
包括验证活动在内的项目项目经理
Drive progress of validation activities in project in accordance with relevant procedures and instructions.
根据相关程序和指示推动项目验证活动的进展。
d.QA in GxP areas GXP地区的质量保证
Ensure that validation processes are performed according to relevant procedure and instructions.
确保验证过程按照相关程序和指令执行。
Challenge validation activities and content of the validation documentation to assure compliance and quality.
挑战验证活动和验证文件的内容，以确保符合性和质量。
