INTRODUCTION
序论
护理法律法规
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 reprent key opportunities for manufacturers, engineering professionals, and equipment suppliers. The systems are required to meet current Good Manufacturing Practice cGMP regulations while remaining in compliance with all other governing codes, laws, and regulations.
对制造商、工程专家和设备供应商而言，制药企业水和蒸汽系统的设计、构造和验证（委托和确认）意味着重要机会。在需要符合其他管理法规、法律和法规的同时，这些系统也需要符合cGMP法规。
黄鹤楼诗句The cost of bringing the systems on line is highly variable, owing to interpretation of
regulatory requirements and overly conrvative design approaches. This Guide is intended to offer a practical, consistent interpretation, while still allowing flexibility and innovation.
由于对调控需求和过度保守设计方式的理解，使得这些在线系统的成本有很大差异。在仍然允许灵活和创新的同时，本指南旨在提供一个实用的，一致的理解。
高考指导This Guide was prepared by ISPE, with feedback from industry reprentatives from all areas and disciplines, and comments provided by FDA. It reflects ISPE's current thinking related to engineering of new water and steam systems.
本指南由ISPE编纂，参考来自所有领域和学科的企业代表的反馈，并由FDA注释。它反映了ISPE关于新水和蒸汽系统工程当前的思想。
It is recognized that industry standards evolve, and this document reflects the understanding of them as of the publication date.
企业标准逐步形成，并且该文件反映在其发行日期时对标准的理解，这是公认的。
1.2 SCOPE OF THIS GUIDE 本指南的适用范围
This Guide is intended for the design, construction, and operation of new water and steam systems. It is neither a standard nor a detailed design guide. The validation of water and steam systems, which compris commissioning and qualification activities, will not be discusd indepth in this Guide, but is covered in the Commissioning and Qualification Baline Guide.
本指南用于新水和蒸汽系统的设计，建造和运行。它既不是一个标准也不是详细的设计指南。包含委托和确认行为的水和蒸汽系统的验证，将不会在本指南中深入彻底地讨论，但是会在委托和确认基线指南中涉及。
番茄鱼片The purpo of this Guide is to focus on engineering issues, and provide cost effective water and steam systems. Where non-engineering issues (e.g., microbiological topics) are covered, the information is included to stress the importance of such topics and the impact they have on water and steam system design.Such non-engineering topics, therefore, are not covered comprehensively, and specific advice from QA departments an
d technical experts must be sought where technical input is required.
本指南将目标集中在工程问题上，并提供了水和蒸汽系统的有效成本。在包含非工程问题（例如，微生物问题）的地方，也包含这些信息，来强调在水和蒸汽系统设计方面出现的问题及其影响的重要性。因此并不是广泛包含这些非工程问题，同时在需要技术输入的地方应当征求QA部门和技术专家的建议。
This Guide is intended primarily for regulatory compliance for the domestic United States (US) market, and follows US standards and references. European and other non-US standards and references may be incorporated in future revisions.
本指南主要是为了调控适应美国国内市场，并遵循美国标准及参考。欧洲和其他非美国标准及参考可能在将来的修订版中合并。
1.3 SOME APPLICABLE FDA CURRENT REGULATIONS AND GUIDES FOR PHARMACEUTICAL WATER SYSTEMS一些适用于制药水系统的FDA现行法规和指南
● Food and Drug and Cosmetic Act
少女的心手抄本● The United States Pharmacopoeia XXIV
● Title 21 CFR, Part 211
● FDA Guide To Inspections of High Purity Water Systems
● 食品，药品和化妆品法案
● USP XXIV
● 联邦管理法规第211部分，第21条
● FDA高纯水系统检查指南
1.4 KEY CONCEPTS墙面设计重要概念
The following key concepts covered in this Guide are:
下列在本指南中涉及的重要概念为：
a) Methodology for defining the required water quality and configuring a water delivery system.
b) Critical process parameters.
c) Good Engineering Practices.
d) Design Options
海岛旅游a) 规定所需水质和配置输水系统的方法论
b) 关键过程参数
c) 良好的工程管理规范.
d) 设计方案
a) Methodology for defining the required quality and configuring a water delivery system:规定所需水质和配置输水系统的方法论
Perhaps the most critical step in a new pharmaceutical water or steam system, from a regulatory
as well as technical and financial standpoint, is the specification of water or steam quality required. The specification established is likely to have a larger impact on lifecycle costs of the system than any of the subquent design decisions. In addition, regulated industries must consider the costs of noncompliance and water system failures. Therefore, it is esntial for the designer to ek advice from the Quality unit and technical experts early in the process.
除技术和财务之外的调控观点认为，在新制药用水或蒸汽系统中也许大多数重要步骤是水或蒸汽质量所需的技术指标。相较后来的设计决定而言，建立的技术要求似乎对系统的生命周期成本影响更大，此外，规范的企业必须考虑不合格情况和水系统失败的花费。因此，在这个过程中，设计者很有必要及早征求质量部门和技术专家的建议。
Once process water and/or steam requirements are determined, system design options need to be
大理寺addresd. This Guide prents alternative baline water and steam system building blocks and associated advantages and disadvantages of each. The baline building blocks are qualified relative to such things as capital costs; feed water chemistry; product water quality; chemical handling; water consumption; energy consumption; outside rvice costs maintenance requirements; and chemical/microbial/endotoxin removal performance.
