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世卫组织药理学制剂规范专家委员会报告who expert committee on specifications for phamarceutical preparations

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  • 2020-11-10 21:53:15
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WHOExpertCommitteeonSpecificationsforPharmaceuticalPreparations992WHOTechnicalReportSeriesTheExpertCommitteeonSpecificationsforPharmaceuticalPreparationsworkstowardsclear,independentandpracticalstandardsandguidelinesforthequalityassuranceofmedicines.StandardsaredevelopedbytheCommitteethroughworldwideconsultationandaninternationalconsensus-buildingprocess.Thefollowingnewguidelineswereadoptedandrecommendedforuse.RevisedprocedureforthedevelopmentofmonographsandothertextsforTheInternationalPharmacopoeia;RevisedupdatingmechanismforthesectiononradiopharmaceuticalsinTheInternationalPharmacopoeia;Revisionofthesupplementaryguidelinesongoodmanufacturingpractices:validation,Appendix7:non-sterileprocessvalidation;Generalguidanceforinspectorsonhold-timestudies;16technicalsupplementstoModelguidanceforthestorageandtransportoftime-andtemperature-sensitivepharmaceuticalproducts;Recommendationsforqualityrequirementswhenplant-derivedartemisininisusedasastartingmaterialintheproductionofantimalarialactivep

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