ISPE-Good_Engineering_Practice良好的工程质量管理规范GEP(95Pages).pdf

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。 Acknowledgements 鸣谢 The ISPE Good Practice Guide (GPG): Good Engineering Practice (GEP) was produced by a Task Team led by Chris Derrett {Schering-Plough Corp., USA) and Mark Foss (Boehringer Ingelheim Ltd., United Kingdom). The members of the task team contributed and reviewed new material. John Andrews Andrews Consulting Enterprises Ltd. United Kingdom Joesph Berka Fluor USA Nuala Calnan PM Group Ireland Tim Cronin Boehringer Ingelheim United Kingdom Nick Davies GlaxoSmithKline United Kingdom Frank DeMarinis Purdue Pharma LP USA Phil DeSantis Schering-Plough Corp. USA R