WHO生物制品技术法规与检查指导文献.docx

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WHO生物制品技术法规与检查指导文献.docx

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WHOgoodmanufacturingpracticesforpharmaceuticalproducts:mainprinciples.WHOExpertCommitteeonSpecificationsforPharmaceuticalPreparations.Forty-eightReportGeneva,WorldHealthOrganization,2014(WHOTechnicalReportSeries,No.986),Annex2.

Shortname:WHOTRSNo.986,Annex2

/medicines/areas/quality_safety/quality_assurance/expert_committee/trs_986/en/

WHOGoodManufacturingPractices:waterforpharmaceuticaluse.WHOExpertCommitteeonSpecificationsforPharmaceuticalPreparations.Fourth-sixReport.Geneva,WorldHealthOrganization,2012(WHOTechnicalReportSeries,No.970),Annex2

Shortname:WHOTRSNo.970,Annex2

/medicines/areas/quality_safety/quality_assurance/expert_committee/trs_970/en/

WHOTRSNo.1033,Annex3WHOgoodmanufacturingpractices:waterforpharmaceuticaluse（上面的应该不是最新的，确认下1033应该是最新的）

WHOguidelinesforsamplingofpharmaceuticalproductsandrelatedmaterials.WHOExpertCommitteeonSpecificationsforPharmaceuticalPreparations.Thirty-ninthReport.Geneva,WorldHealthOrganization,2005(WHOTechnicalReportSeries,No.929),Annex4

Shortname:WHOTRSNo.929,Annex4

/trs/WHO_TRS_929_eng.pdf?ua=1

Supplementaryguidelinesongoodmanufacturingpractices:validation.WHOExpertCommitteeonSpecificationsforPharmaceuticalPreparations.FortiethReport.Geneva,WorldHealthOrganization,2006(WHOTechnicalReportSeries,No.937),Annex4

Shortname:WHOTRSNo.937,Annex4

/trs/WHO_TRS_937_eng.pdf?ua=1

WHOGoodPracticesforPharmaceuticalQualityControlLaboratories.WHOExpertCommitteeonSpecificationsforPharmaceuticalPreparations.Forty-fourthReport.Geneva,WorldHealthOrganization,2010(WHOTechnicalReportSeries,No.957,Annex1

Shortname:WHOTRSNo.961,957),Annex1

/medicines/publications/44threport/en/

WHOGoodPracticesforPharmaceuticalProductsContainingHazardousSubstances.WHOExpertCommitteeonSpecificationsforPharmaceuticalPreparations.Forty-fourthRep