PDA TR06无菌粉末灌装工艺验证-（英文）.docxVIP

TechnicalReportNo.6

Validationof

AsepticDrugPowder

FillingProcesses

PARENTERALDRUGASSOCIATION,

INC.

7500OldGeorgetownRoad,Suite620

Bethesda,Maryland20814

FOREWORD

THISISTHESIXTHINASERIESOFTECHNICALREPORTS.1-5Thistechnicalreportwasproducedtoserveasaguideoutliningastep-by-stepapproachtovalidatetheasepticdrugpowderfillingprocess.However,itdoesnotexcludetheuseofalternatemethodstovalidatetheasepticdrugpowderfillingprocess.ThereportwasdirectedbytheQualityControlSubcommitteeoftheResearchCommitteeoftheParenteralDrugAssociation.ThetaskforcewhichdevelopedthisreportwaschairedbyJohnWasynczuk,andwasco-editedbyGordonBeyerleandDorisConrad.Thereportincludesphilosophy,materials,equipment,operatingparameters,validation,andrevalidationapproaches.

Thevalidationapproachcontainedhereinshouldbetreatedasaguidelineonlyandnotasarequirementforvalidation.ThistechnicalreportisonlyintendedtoprovideinformationtothePDAmembershipandshouldnotbeconstruedasarecommendationofthePDA.

FloydBenjaminChairman

ResearchCommittee

1“ValidationofSteamSterilzationCycles,”ParenteralDrugAssociationInc.,TechnicalMonographNo.1.

2“ValidationofAsepticFillingforSolutionDrugProducts,”ParenteralDrugAssociationInc.,TechnicalMonographNo.2.

3ValidationofDryHeatProcessesUsedforSterilizationDepyrogenation,ParenteralDrugAssociationInc.,TechnicalReportNo.3.

4DesignConceptsfortheValidationofaWaterforInjectionSystem,ParenteralDrugAssociationInc.,TechnicalReportNo.4.

5“SterilePharmaceuticalPackaging:CompatibilityandStability,”ParenteralDrugAs-sociation,Inc.,TechnicalReportNo.5.

PREFACE

In1980,theParenteralDrugAssociationpublishedTechnicalMono-graphNo.2entitled,“Validationof