纯 化水的检测精品参考资料.docVIP

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: 责 任 人 操 作 RESPONSIBILITY ACTION 1. 系统描述 SYSTEM DESCRIPTION 1.1 纯化水系统由2部分组成： Purified water system consists of 2 portions: 1.1.1 制备系统：包括相应的设备单元和管路。 Generator system：Elements include the appropriate equipment unit and the pipes. 1.1.2 循环管路系统：纯化水的循环分配管路。 Pipe loop: Distribution loop. 1.2 纯化水系统中的使用点和取样点，见附件1。 The point-of-use and sampling point locations in the purified water system please see Attachment 1. 2. 日常监测 ROUTINE MONITORING 2.1 监测点及监测频率 Monitoring points and sampling frequency 2.1.1 循环管路 Pipe loop 2.1.1.1 对于有4至7天的正常工作周，每周（至少每隔2～3天1次）取样监测2次。如果工作周