ispe-goodengineeringpractice良好的工程質(zhì)量管理規(guī)范gep95pages

1、 ISPE Good Practice Guide 國際制藥工程協(xié)會：良好的實踐指南 Good Engineering Practice 良好的工程質(zhì)量管理 Preface 緒言 This ISPE Good Practice Guide: Good Engineering Practice (GEP) aims to provide both a definition and explanation of the term “Good

2、 Engineering Practice.“ The Guide covers the complete life cycle of engineering, from concept to retirement, and describes the fundamental elements of GEP as they should exist in pharmaceutical and related industries. 此指

3、南：旨在推動對 GEP 規(guī)定的概念和原則的共同理解及解釋術(shù)語“良好的工程實踐”。 以及介紹的基本要素中他們應(yīng)該存在于醫(yī)藥及相關(guān)產(chǎn)業(yè)， 并且描述了應(yīng)該存在于制藥和相關(guān)產(chǎn)業(yè)的基本元素。 It brings together a wealth of information on GEP and provides tools to allow benchmarking of current company practices against w

4、hat is considered industry good practice 它匯集了 GEP 豐富的信息并且提供了現(xiàn)代的、被認(rèn)為是行業(yè)的良好做法工具。 The Guide includes attachments which provide industry examples, currently in use, of GEP and auditing methods, together with checklists that

5、may be of use to the reader. 該指南包含的附件提供了行業(yè)的例子，目前使用的方法，以及審計方法，連同可供審稿人使用的清單。 Acknowledgements 鳴謝 1.1 Overview 概述 1.2 Purpose 目的 1.3 Scope and Benefit Objectives 范圍和效益目標(biāo) 8 1.4 Key Concepts 關(guān)鍵概念 1

6、.5 Structure of the Guide 結(jié)構(gòu)的指南 2 Breadth and Coverage of GEP 11 GEP的廣度和范圍 3 Good Engineering Practice 良好的工程實踐 良好的工程實踐 13 3.1 Core Concepts 核心內(nèi)容 3.3

7、Project Engineering 項目工程 15 3.3 Common Practices 常見的實踐方法 3.4 Operations and Maintenance 操作和維護(hù) 32 4 Appendix

8、 1 - Explanation of Example Engineering Management Process 39 附錄 附錄1 -解釋示范工程管理過程 解釋示范工程管理過程 5 Appendix 2 - Glossary and Acronyms 41 附錄 附錄2 -詞匯和縮略語 詞匯和縮略語 5.1 Glossary 詞匯表 6 Acronyms and Abbrev