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1、INTRODUCTION序论1INTRODUCTION序论1.1BACKGROUND背景Thedesign,construction,andvalidation(commissioningandqualification)ofwaterandsteamsystemsforthepharmaceuticalindustryrepresentkeyopportunitiesformanufacturers,engineeringprofessionals,andequipmentsuppliers.Thesesystemsarerequiredtomeetcur
2、rentGoodManufacturingPracticecGMPregulationswhileremainingincompliancewithallothergoverningcodes,laws,andregulations.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。Thecostofbringingthesesystemsonlineishighlyvariable,owingtointerpretationofr
3、egulatoryrequirementsandoverlyconservativedesignapproaches.ThisGuideisintendedtoofferapractical,consistentinterpretation,whilestillallowingflexibilityandinnovation.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。ThisGuidewaspreparedbyISPE,withfeedbackfromindus
4、tryrepresentativesfromallareasanddisciplines,andcommentsprovidedbyFDA.ItreflectsISPE'scurrentthinkingrelatedtoengineeringofnewwaterandsteamsystems.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。Itisrecognizedthatindustrystandardsevolve,andthisdocumentreflectstheund
5、erstandingofthemasofthepublicationdate.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。1.2SCOPEOFTHISGUIDE本指南的适用范围ThisGuideisintendedforthedesign,construction,andoperationofnewwaterandsteamsystems.Itisneitherastandardnoradetaileddesignguide.Thevalidationofwaterandsteamsystems,whichcomprisescom
6、missioningandqualificationactivities,willnotbediscussedindepthinthisGuide,butiscoveredintheCommissioningandQualificationBaselineGuide.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。ThepurposeofthisGuideistofocusonengineeringissues,andp
7、rovidecosteffectivewaterandsteamsystems.Wherenon-engineeringissues(e.g.,microbiologicaltopics)arecovered,theinformationisincludedtostresstheimportanceofsuchtopicsandtheimpacttheyhaveonwaterandsteamsystemdesign.Suchnon-engineeringtopics,therefore,arenotcoveredcomprehensively,andspec
8、ificadvicefromQAdepartment
