性能确认PQ(中英文)

YUNG SHIN PHARM.IND.(KS)CO.,LTD 永信药品工业（昆山）有限公司 Code: VP402 编号: Page: 1 OF 22 第 1 页 共 22 页 Purified Water System Performance Qualification 纯化水系统性能确认 Version: A 版本: Date: 日期: 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 YUNG SHIN PHARM.IND.(KS)CO.,LTD 永信药品工业（昆山）有限公司 Code: VP402 编号: Page: 2 OF 22 第 2 页 共 22 页 Purified Water System Performance Qualification 纯化水系统性能确认 Version: A 版本: Date: 日期: 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 ............................................................................................................................