文档介绍：修订记录/ Revision history:
:初始版本
Release Initial Release
部门
Function
姓名
Name
签名
Signature
日期
Date
制定人
Author
验证代表
Validation representative
审核人
Reviewers
维修保养部门代表Maintenance representative
批准人
Approver for English version
QA 经理
QA manager
批准人
Approver for bilingual version
管理者代表
Management representative
目的/ PURPOSE
此文件的目的是为了建立书面上的依据,表明纯水的产生,储存,管道的运行都是根据供应商的规格来操作,并且能够根据用户需求生产,储存和提供纯水。
The purpose of the present Operational Qualification Protocol is to establish documentary evidence that Purified Water System (Generation, Storage and Distribution ) works in accordance with operation supplier specifications, and it is able to produce, store and provide water according to user requirements.
本文件检查水系统的自动化,系统警报和回路中水的流速
This protocol will check the automatism and system's alarms as well as the pressure regulation of the water through the loop.
认证策略/STRATEGY OF THE QUALIFICATION
由有资质的技术人员进行认证,包括几个测试的执行,以此来验证安装是否合格。
Qualified technical personnel will carry out the verification. It will consist in the execution of several tests that will allow the verification that the installation works in accordance with its purpose.
系统包括几个测试来验证安装的功能,也包括一些不利情况或“最坏情况”测试来验证系统在紧张情况下的坚固性。
The system will be subjected to several tests in order to verify the functionality of the installation, and it will be also subjected to unfavorable situations or “worst case” tests in order to verify the system’s robustness in front of stress situations.
参考法规与文件/ DOCUMENT REFERENCES
文件编号/ Reference No.
文件标题/Title
URS 0024
药业厂房要求
User requirement specification for JV building
SBE-GP-003R01
验证主程序
General Procedure for validation
职责/ RESPONSIBILITIES
步骤/ Steps
部门/ Department
执行测试/Test Execution
技术代表和供应商
Technical representative and supplier
测试结果审核/ Test Verification
验证部门代表
Validation representative
验证报告撰写/ Writing the report
验证部门代表
Validation representative
验证方案设计理由/ QUALIFICATION STRATEGY
进行操作验证测试来确认主要参数及合格标准
The operation qualification tests