世卫组织药理学制剂规范专家委员会报告whoexpertcommitteeonspecificatio

WHOExpertCommitteeonSpecificationsforPharmaceuticalPreparations992WHOTechnicalReportSeriesTheExpertCommitteeonSpecificationsforPharmaceuticalPreparationsworkstowardsclear,independentandpracticalstandardsandguidelinesforthequalityassuranceofmedicines.StandardsaredevelopedbytheCommitteethroughworldwideconsultationandaninternationalconsensus-buildingprocess.Thefollowingnewguidelineswereadoptedandrecommendedforuse.RevisedprocedureforthedevelopmentofmonographsandothertextsforTheInternationalPharmacopoeia;RevisedupdatingmechanismforthesectiononradiopharmaceuticalsinTheInternationalPharmacopoeia;Revisionofthesupplementaryguidelinesongoodmanufacturingpractices:validation,Appendix7:non-sterileprocessvalidation;Generalguidanceforinspectorsonhold-timestudies;16technicalsupplementstoModelguidanceforthestorageandtransportoftime-andtemperature-sensitivepharmaceuticalproducts;Recommendationsforqualityrequirementswhenplant-derivedartemisininisusedasastartingmaterialintheproductionofantimalarialactivepharmaceuticalingredients;Multisource(generic)pharmaceuticalproducts:guidelinesonregistrationrequirementstoestablishinterchangeability:revision;Guidanceontheselectionofcomparatorpharmaceuticalproductsforequivalenceassessmentofinterchangeablemultisource(generic)products:revision;andGoodreviewpractices:guidelinesfornationalandregionalregulatoryauthorities.WHOTechnicalReportSeries992Forty-ninthreportWHOExpertCommitteeonSpecificationsforPharmaceuticalPreparationsTheWorldHealthOrganizationwasestablishedin1948asaspecializedagencyoftheUnitedNationsservingasthedirectingandcoordinatingauthorityforinternationalhealthmattersandpublichealth.OneofWHO’sconstitutionalfunctionsistoprovideobjectiveandreliableinformationandadviceinthefieldofhumanhealth,aresponsibilitythatitfulfilsinpartthroughitsextensiveprogrammeofpublications.TheOrganizationseeksthroughitspublicationstosupportnationalhealthstrategiesandaddressthemostpressingpublichealthconcernsofpopulationsaroundtheworld.TorespondtotheneedsofMemberStatesatalllevelsofdevelopment,WHOpublishespracticalmanuals,handbooksandtrainingmaterialforspecificcategoriesofhealthworkers;internationallyapplicableguidelinesandstandards;reviewsandanalysesofhealthpolicies,programmesandresearch;andstate-of-the-artconsensusreportsthatoffertechnicaladviceandrecommendationsfordecision-makers.ThesebooksarecloselytiedtotheOrganization’spriorityactivities,encompassingdiseasepreventionandcontrol,thedevelopmentofequitablehealthsystemsbasedonprimaryhealthcare,andhealthpromotionforindividualsandcommunities.ProgresstowardsbetterhealthforallalsodemandstheglobaldisseminationandexchangeofinformationthatdrawsontheknowledgeandexperienceofallWHO’sMembercountriesandthecollaborationofworldleadersinpublichealthandthebiomedicalsciences.Toensurethewidestpossibleavailabilityofauthoritativeinformationandguidanceonhealthmatters,WHOsecuresthebroadinternationaldistributionofitspublicationsandencouragestheirtranslationandadaptation.Byhelpingtopromoteandprotecthealthandpreventandcontroldiseasethroughouttheworld,WHO’sbookscontributetoachievingtheOrganization’sprincipalobjective–theattainmentbyallpeopleofthehighestpossiblelevelofhealth.TheWHOTechnicalReportSeriesmakesavailablethefindingsofvariousinternationalgroupsofexpertsthatprovideWHOwiththelatestscientificandtechnicaladviceonabroadrangeofmedicalandpublichealthsubjects.Membersofsuchexpertgroupsservewithoutremunerationintheirpersonalcapacitiesratherthanasrepresentativesofgovernmentsorotherbodies;theirviewsdonotnecessarilyreflectthedecisionsorthestatedpolicyofWHO.Anannualsubscriptiontothisseries,comprisingaboutfourtosixsuchreports,costsCHF150.00/US$180.00(CHF105.00/US$126.00indevelopingcountries).Forfurtherinformation,pleasecontact:WHOPress,WorldHealthOrganization,20AvenueAppia,1211Geneva27,Switzerland(tel.[phone];fax:[phone];email: [e-mail];orderonline:).TheInternationalPharmacopoeia,fourthedition.Volume1:generalnotices;monographsforpharmaceuticalsubstances(A–O)Volume2:monographsforpharmaceuticalsubstances(P–Z);monographsfordosageformsandradiopharmaceuticalpreparations;methodsofanalysis;reagents.2006(1500pages),alsoavailableonCD-ROMandonlineFirstsupplement:generalnotices;monographsforpharmaceuticalsubstances;monographsfordosageforms;generalandspecificmonographs;methodsofanalysis;InternationalChemicalReferenceSubstances;InternationalInfraredReferenceSpectra;reagents,testsolutionsandvolumetricsolutions.2008(309pages),alsoavailableonCD-ROMandonlineSecondsupplement:generalnotices;monographsforpharmaceuticalsubstances andradiopharmaceuticals;monographsfordosageforms;generalandspecificmonographs;methodsofanalysis;InternationalChemicalReferenceSubstances;InternationalInfraredReferenceSpectra;reagents,testsolutionsandvolumetricsolutions.Third(2013)andFourthsupplementsasaboveandallsupplementsfocusingonessentialmedicinesincludingnewmonographsforantiretrovirals,antimalarials,antituberculosisandpaediatricmedicines.2014(CD-ROMandonline)Basictestsfordrugs:pha