Quality Assurance PharmVol2

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1、QAPPR12/16/0612:10PMPageiQualityassuranceofpharmaceuticalsAcompendiumofguidelinesandrelatedmaterialsVolume2,2ndupdatededitionGoodmanufacturingpracticesandinspectionQAPPR12/16/0612:10PMPageiiWHOLibraryCataloguing-in-PublicationDataQualityassuranceofpharmaceuticals:acomp

2、endiumofguidelinesandrelatedmaterials.ndVol.2,Goodmanufacturingpracticesandinspection.–2ed.1.Drugandnarcoticcontrol–standards2.Drugindustry–standards3.Pharmaceuticalpreparations–standards4.Biologicalproducts–standards5.Qualitycontrol6.GuidelinesI.WorldHealthOrganizatio

3、nII.Title:GoodmanufacturingpracticesandinspectionISBN9241547081(NLMclassification:QV33)ISBN9789241547086©WorldHealthOrganization2007Allrightsreserved.PublicationsoftheWorldHealthOrganizationcanbeobtainedfromWHOPress,WorldHealthOrganization,20AvenueAppia,1211Geneva27,Swi

4、tzerland(tel.:+41227913264;fax:+41227914857;e-mail:bookorders@who.int).RequestsforpermissiontoreproduceortranslateWHOpublications–whetherforsaleorfornoncom-mercialdistribution–shouldbeaddressedtoWHOPress,attheaboveaddress(fax:+41227914806;e-mail:permissions@who.int).Th

5、edesignationsemployedandthepresentationofthematerialinthispublicationdonotimplytheexpressionofanyopinionwhatsoeveronthepartoftheWorldHealthOrganiza-tionconcerningthelegalstatusofanycountry,territory,cityorareaorofitsauthorities,orconcerningthedelimitationofitsfrontiers

6、orboundaries.Dottedlinesonmapsrepresentapproximateborderlinesforwhichtheremaynotyetbefullagreement.Thementionofspecificcompaniesorofcertainmanufacturers’productsdoesnotimplythattheyareendorsedorrecommendedbytheWorldHealthOrganizationinpreferencetoothersofasimilarnaturet

7、hatarenotmentioned.Errorsandomissionsexcepted,thenamesofproprietaryproductsaredistinguishedbyinitialcapitalletters.AllreasonableprecautionshavebeentakenbytheWorldHealthOrganizationtoverifytheinformationcontainedinthispublication.However,thepublishedmaterialisbeingdis-t

8、ributedwithoutwarrantyofanykind,eitherexpressedorimplied.Theresponsibilityfortheinterpretationanduseofthemateriallies