性能确认PQ(中英文).docVIP

EXECUTION APPROVAL SIGNATURES 批准执行签名 The signatures below indicate approval of this protocol and its attachments and indicate that it is ready for execution. Any changes or modifications to the intent or the acceptance criteria of this protocol, following approval, requires the generation of an amendment which must be approved prior to execution. 下面的签名表示批准本文件及其附件，且表明已经为执行作好了准备。在批准后，对本文件的目的或验收标准进行的任何改变或修正都必须起改善的作用，在执行以前就必须取得批准。 Department Site 单位部门 Signature Date 签名与日期 Issued by 起草 Reviewed by 审核 Authorized by 批准 Contents目录 1.0 SCOPE 范围 3 2.0 PURPOSE 目的 3 3.0 BACKGROUND 背景 3 4.0 INTRODUCTION 介绍 3 5.0 REFERENCES 参考书目 4 6.0 RESPONSIBLE PARTIES AND RESPONSIBILITIES 责任方及其责任 4 7.0 SYSTEM DESCRIPTION 系统说明 6 General Description 总说明 6 Pretreatment Unit 预处理单元 6 Reverse Osmosis (RO) System 反渗透 (RO) 系统 7 Mixed Bed System 混床系统 8 Monitor and Control System 监视和控制系统 9 8.0 TESTING PROCEDURES 检验程序 9 9.0 ACCEPTANCE CRITERIA 验收标准 10 Attachment 1 - Validation Test Equipment and Materials 附件1 – 验证测试设备和材料 11 Attachment 2 – PW System 30 Day Sampling Plan Data Sheet 附件2 – 纯化水系统30天取样计划数据表 12 Attachment 3 – 2nd Phase PW System Sampling Plan Data Sheet 附件3 – 纯化水系统第二阶段取样计划数据表 15 Attachment 4 - PW Sample Test Result Form 附件4 - PW样品测试结果表 18 Attachment 5 - Signature Verification List 附件5 - 签名确认清单 19 Attachment 6 - Protocol Deviation Log 附件6 -文件偏差日志 20 Attachment 7 - Protocol Deviation Record 附件7 - 文件偏差记录 21 Attachment 8 - Protocol Execution Approval Signatures Data Sheet 附件8 -文件执行批准签名数据表 22 1.0 SCOPE范围 This Performance Qualification (PQ) study will be performed on the Purified Water (PW) System, located in YUNG SHIN PHARM.IND.(KS)CO.,LTD.. The scope of this protocol will be for the initial 30 days of aggressive sampling. An additional eleven months of sampling will be performed per a YUNG SHIN PHARM.IND.(KS)CO.,LTD. SOP to establish an entire year of sample results. 本性能确认（PQ）文件应用于位于永信药品工业（昆山）有限公司的纯化水（PW）系统。本文件的范围将涵盖初始30天的取样。再附上11个月的取样情况，得到整一年的取样