GEP良好工程质量管理规范—药智论坛.pdf

如果想要下载更多的资源请百度一下药智论坛 ISPE Good Practice Guide 国际制药工程协会：良好的实践指南 Good Engineering Practice 良好的工程质量管理 Preface 绪言 This ISPE Good Practice Guide: Good Engineering Practice (GEP) aims to provide both a definition and explanation of the term Good 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. 此指南：旨在推动对 GEP 规定的概念和原则的共同理解及解释术语“良好的工程实践”。 以 及介绍的基本要素中他们应该存在于医药及相关产业，并且描述了应该存在于制药和相关产 业的基本元素。 It brings together a wealth of information on GEP and provides tools to allow benchmarking of current company practices against what is considered industry good practice 它汇集了 GEP 丰富的信息并且提供了现代的、被认为是行业的良好做法工具。 The Guide includes attachments which provide industry examples, currently in use, of GEP and auditing methods, together with checklists that may be of use to the reader. 该指南包含的附件提供了行业的例子，目前使用的方法，以及审计方法，连同可供审稿人使 用的清单。 Table of Contents 本资料由药智论坛收集整理，仅供学习使用，任何单位或个人不得用于商业用途 如果想要下载更多的资源请百度一下药智论坛 目录 1 Introduction 7 1.1 Overview 概述 1.2 Purpose 目的 1.3 Scope and Benefit Objectives 范围和效益目标 1.4 Key Concepts 关键概念 1.5 Structure of the Guide 结构的指南 2 Breadth and Coverage of GEP GEP的广度和范围 3 Good Engineering Practice 良好的工程实践 3.1 Core Concepts 核心内容 3.3 Project Engine 项目工程 3.3 Common Practices 常见的实践方法 3.4 Operations and Maintenance 操作和维护 4 Appendix 1 - Explanation of Example Engineering Management Process 附录1 -解释示范工程管理过程 5 Appendix 2 - Glossary and Acronyms 附录2 -词汇和缩略语 5.1 Glossary 词汇表 6 Acronyms and Abbreviations 缩略语和缩写 7 Appendix 3 –References 附录三—