欧洲GMP自检确认表.doc

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1、GMPChecklistforActivePharmaceuticalIngredients(APIs)ThisGMPchecklistisbasedonregulatoryrequirementsandpersonalexperiences.I.OrganizationandPersonnelA.ResponsibilitiesoftheQualityUnit(QU)ThereshouldbeaQUthatisindependentofproduction.QUshouldbeinvolvedinallq

2、ualityrelatedmatters.QUhastheresponsibilitytorelease/rejectallmaterials,intermediates,andAPIs,reviewsandapprovesallqualityrelateddocuments.QUensuresthatcriticaldeviationshavebeenfullyinvestigatedandresolved.QUreviewsandapproves/rejectsintermediatesandAPIsp

3、rocessed,packaged,orheldundercontractbyanothercompany.QUestablishesappropriatequalitysystems.QUisresponsibleforreviewandapprovalof:·CompletedbatchproductionandlabcontrolrecordspriortoAPIrelease·Allspecificationsandmasterproductioninstructions·Allprocedures

4、(e.g.SOPs)potentiallyimpactingAPIquality·Validationprotocolsandreports·ChangesimpactingAPIqualityQUensuresthat:·Qualityrelatedcomplaintsareinvestigatedandresolved·Materialsareappropriatelytestedandresultsarereported·Effectivesystemsareusedformaintainingand

5、calibratingcriticalequipment·Stabilitydataarecreatedtosupportretestdatesandstorageconditions·Internalauditsareperformedregularlywithanapprovedschedule·Auditfindingsandcorrectiveactionsaredocumentedandbroughttotheattentionofresponsiblemanagement·Productqual

6、ityreviews(preferredannually)areperformed·Adequatelabfacilitiesareavailabletotestallmaterials,intermediatesandAPIs.QUmaydelegatetheresponsibilityforin-processtestingandreleaseofintermediatestoproductionunit.B.ResponsibilitiesoftheProductionUnitPrepares,rev

7、iews,approvesanddistributestheinstructionsforAPIproductionaccordingtowrittenprocedures.ProducesAPIsaccordingtopre-approvedinstructionsbyQU.Reviewsallproductionrecordsforcompletionandsignsthemoff.Ensuresthat:·Allproductiondeviationsarereportedandevaluated·C

8、riticaldeviationsareinvestigatedandconclusionsarerecorded·Productionfacilitiesareclean·Necessarycalibrationsareperformedandrecordskept·Premisesandequipmentaremaintainedandrecordskept·Validationprotocolsandrep