Prove It 良好实践指南: 关键公用系统 GMP合规性 如何做到合规、 并可证明 Disclaimer: This Good Practice Guide is intended to provide guidance on achieving and maintaining critical utility systems compliance, and to be an aid to organizations in preparing and hosting regulatory inspections and audits....
国际制药协会ISPE基础指南05卷[归类].pdf,A GUIDE FOR NEW FACILITIES VOLUME 5: COMMISSIONING AND QUALIFICATION EXECUTIVE SUMMARY JUNE 2000 A DOCUMENT DEVELOPED IN PARTNERSHIP BY: ISPE BASELINE® GUIDE COMMISSIONING AND QUALIFICATION JUNE 2000 2 ISPE BASEL
【附件1】19ISPE_10_调试和确认 COMMISSIONING AND QUALIFICATION 调试和确认
内容提示: GoodPnactice0uideGommi$$ioning andQualilication olPhaFmaccutical Waten and$team $ystem$Disclaimer:This Guide is meant to assist pharmaceutical companies in managing the commissioning and qualification ofpharmaceutical direct impact water and steam systems. The ISPE Critical Utilities COP ...
系统的装配 11.12 缩写和定义 INTRODUCTION 序论 1 INTRODUCTION 序论 1.1 BACKGROUND 背景 The design, construction, and validation (commissioning and qualification) of water and steam systems for the pharmaceutical industry represent key opportunities for manufacturers, engineering professionals, and equipment ...
2、perated under set procedures. Although commissioning and qualification are typically separated within a project schedule, they are in essence, one continuous process. 调试和确认是一个验证过程, 是将系统投入使用并证明其在设定规程的不同条件下运转时始 终能生产合格水质的过程。 虽然在一个项目进步表中...
内容提示: ISPE Baseline® Pharmaceutical Engineering Guides for New and Renovated Facilities: Volume 4, Commissioning and Qualification Page 1 of 172 文档格式:PDF | 页数:172 | 浏览次数:1000 | 上传日期:2012-09-07 12:01:42 | 文档星级: ...
用ISPE 2019.06发布的commissioning and qualification 2nd 调试与确认第二版 交换以下任意一本 Baseline ...
This Guide is meant to assist pharmaceutical companies in managing the commissioning and qualification ofpharmaceutical direct impact water and steam systems. The ISPE Critical Utilities COP cannot ensure and does notwarrant that a system managed in accordance with this Guide will be acceptable to ...
A GUIDE FOR NEW FACILITIES VOLUME 5: COMMISSIONING AND QUALIFICATION EXECUTIVE SUMMARY JUNE 2000 A DOCUMENT DEVELOPED IN PARTNERSHIP BY: ISPE BASELINE GUIDE COMMISSIONING AND QUALIFICATION JUNE 2000 2 ISPE BASELINE GUIDE COMMISSIONING AND QUALIFICATION JUNE 2000 3 ISPE BASELINE GUIDE COMMISSIONING AND ...