Page: SOP#: Eff. Date: Supersedes: 1/9 2-4001.02 2006.12.28 2006.7.1 STANDARD OPERATING PROCEDURE 题目： Title 纯化水系统的质量监测 MONITORING THE PURIFIED WATER SYSTEM 起草/修订人： Author 日期： Date 部门主管审查： Dept. Head Approval 日期： Date QA 批准： Approved by QA 日期： Date 分 发：Distribution: QA、 QC、工程 QA, QC, Engineering 目的： 制订纯化水系统的日常质量监测及偏差处理规程，确保纯化水的质量符合要求。 PURPOSE: This document defines the procedure for routine quality monitoring and deviation disposition on purified water system to ensure the purified water quality meets the requirement. 范围： 适用于公司内纯化水系统（包括纯化水制备系统、纯化水使用点及取样点）的日常质量监测。 在非日常监测（如验证、再验证以及要求的研究）期间，根据具体的监测方案进行；在此期间相关的日常监测暂停。 SCOPE: This SOP is applicable to the routine monitoring on purified water system (including purified water generator system, use points and sampling points) During the non-routine monitoring period (such as validation, re-validation and special studies), the monitoring will be conducted in accordance with the specific protocol. The routine monitoring can be paused during such non-routine monitoring period. 参考文件： REFERENCE AND ATTACHMENT: SOP/题目 SOP/TITLE 记录/附件/题目 FORMS/ATTACHMENTS/TITLE 1-3002 偏差调查 附件1： 纯化水系统中的使用点和取样点 Deviation Investigations Attachment 1: Point-of-use and sampling point locations in the purified water system F-02-014 纯化水系统取样记录 Purified water system sampling logbook 定 义： N/A DEFINITIONS: 规 程： PROCEDURE: Page: SOP#: Eff. Date: Supersedes: 2/9 2-4001.02 2006.12.28 2006.7.1 STANDARD OPERATING PROCEDURE 题目： Title 纯化水系统的质量监测 MONITORING THE PURIFIED WATER SYSTEM 责 任 人 操 作 RESPONSIBILITY ACTION 1. 系统描述 ...
