在线监测系统要求

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1、THEPHARMACEUTICALANDHEALTHCARESCIENCESSOCIETYBESTPRACTICEFORPARTICLEMONITORINGINPHARMACEUTICALFACILITIESTechnicalMonographNo.16CONTENTSPAGE目录1Foreword1、前言2Acknowledgments62、确认3Introduction73、介绍4AirparticlemonitoringtoEUGMPAnnex1:200884、欧盟GMP中关于空气粒子监测的附件5Sys

2、temdesign145、系统设计6Operations256、操作7MaintenanceandCleaning307、保养和清洁8DisasterRecoveryandDataBack-up328、容灾恢复和数据备份9Training339、培训10AppendixA-Workedexampleofmonitoringsystemlayout...3410、附件A：监控系统布局的成功案例11AppendixB-Manifoldandremoteparticlemonitoringsystems3611、附

3、件B：集成和远程粒子监控系统的案例12AppendixC-Examplesofparticlelossintransporttubing3912、附件C：管道输送中粒子损失的案例13AppendixD-Isokineticprobes4213、附件D：等动力采样头14AppendixE-Validationandriskassessmentstandardsandguidelines4314、附件E：验证和风险评估的标准与指导方针1FOREWORD前言ThePharmaceuticalandHealthcar

4、eSciencesSociety(PHSS)existsasasciencebasedforumforindividualsactiveinthefieldsofPharmaceuticalandHealthcareSciences.ThesocietyevolvedfromtheformerParenteralSociety,whichwasprimarilyfocusedonsterileinjectableandimplantabledrugsanddevices,tomeettheneedsofawi

5、dercommunityandbroadenitshorizonsandmembership,withthechangeofnameeffectivefrom1March2006.制药科学和保健学会（PHSS）是研究制药和保健学科，由活跃在制药和保健行业的专家组成的以科学为依据的社会团体。学会前身为注射剂协会，关注无菌注射剂和植入式药品和器械。为适应更多团体的需求，拓展会员并拓宽研究范围，学会从2006年3月1日起改名为制药科学和保健学会（PHSS）ThePHSSobjectivesare:PHSS的宗旨和目

6、标是：1.Tofosterandadvance,intheinterestofpublichealth,pharmaceuticalandhealthcarescienceandpractice.促进和提高制药科学和保健领域的发展；2.Toprovideanddisseminatetoitsmembersinformationconcerningallaspectsofpharmaceuticaltechnologyandadministrationofmedicines.向会员提供和传播各种制药以及给药技术

7、信息3.ToidentifyspecificareaswherethereisaneedfornewinformationorthecollectingtogetherofexistinginformationandtosatisfythisneedbyorganisingmeetingsorbypublishingmonographsorarticlesintheEuropeanJournalofParenteralandPharmaceuticalSciences.通过组织研讨会或在欧洲注射剂和制药协会杂

8、志发表专题论文或文章，识别行业内有需要技术突破的专项领域4.Tofosterandencourageaspiritoffriendlyco-operationamongthemembersofthesocietyandtopromotefavourablerelationsbetweenitsmembersandthemedical,pharmaceutical,hospitalandrelated