发布时间 : 星期三 文章ISPE+1.序论更新完毕开始阅读802c71ebe009581b6bd9eb69
discussions where appropriate.
关键仪器是那些测量关键质量属性的仪器。这个概念在第二章里讨论，它将作为后面适当章节中讨论的基础。
c) Good Engineering Practice (GEP) 工程管理规范(GEP)
GEP recognizes that all systems in a facility, whether they are water systems, steam systems, elevators, process reactors, safety valves, or rest rooms, require some form of commissioning and/or qualification. Nearly all systems require documentation, inspection, and field testing. Good Engineering Practice capitalizes upon this practice suggesting that manufacturers engage all stakeholders (engineers, operators, Quality Assurance, and others) very early in the planning, design, construction, commissioning/qualification phases to ensure that systems are documented only once. GEP认为工厂内的所有系统，不论它们是水系统，蒸汽系统，升降机，过程反应器，安全阀还是洗手间，都需要某些委托和/或确认形式。几乎所有系统都需要文件，检查和实地试验。GEP估价该实践并建议制造商尽早预定在计划、设计、建造、委托/确认阶段中的所有项目干系人（工程师，操作员，QA和其他人员），从而确保系统仅被用文件纪实一次。
d) Design Options设计方案
The Guide emphasizes that a water system can be designed in many different ways, yet meet the overall requirements of the system. It encourages a well-thought-out, planned approach to the design with input from many areas of the organization including Quality Assurance.
本指南强调，水系统可以用不同的方法设计，但是仍然要符合系统的所有要求。它鼓励用一种周密考虑、计划好的方法来进行设计，有来自于包括QA在内的组织区域的输入。
1.5 GUIDE STRUCTURE指南结构
The structure of the Guide is shown in Figure 1-1 below. The chapters have been organized to assist in a logical decision process to determine the type of water required and the system design needed to provide it.
本指南的结构如下表1-1显示。这些章节有机组织起来，以此来达成一个逻辑决定过程，用以确定所需水的类型以及提供它必的系统设计。
Figure 1-1 Pharmaceutical Water and Steam Baseline Guide Structure
表1-1 制药用水和蒸汽系统基线指南结构 Chapter 4 Chapter 1 Pretreatment Options Introduction Chapter 2 Chapter 5 Key Design Final TreatmentOptions: Philosophies NonCompendial &Compendial Purified Water Chapter 6 Chapter 3 Final Treatment Options: Water Options Water for Injection(WFI) and System Planning Chapter 7 Pharmaceutical Steam 章4 章 1 预处理方案 序论 章2 章5 主要设计原理 最终处理方案： 非药典的&药典的纯化水 章6 章 3 水系统方案和设计 最终处理方案： 注射用水(WFI) Chapter 8 Storage and Distribution Systems Chapter 9 Instrumentation &Control Chapter 10 Commissioning Qualification and Chapter 11 Appendix 章8 贮存和分配系统 章9 仪器使用和控制 章10 委托和确认 章11 附录 章7 制药用蒸汽