我也不知道是什么了呀!.docx

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1、5.4ProductPackagingProductpackagingshallbeappropriatefortheintendeduseandshallbestoredunderconditionstominimizecontaminationanddeteriorationRequirements5.4.1Certificatesofconformityorotherevidenceshallbeavailableforproductpackagingtoconfirmitssuitabilityforuse5.4.2Whereappropr

2、iate,packagingshallbestoredawayfromrawmaterialsandfinishedproduct5.4.3Anypart-usedpackagingmaterialssuitableforuseshallbeeffectivelyprotectedbeforebeingreturnedtoanappropriatestoragearea5.4.4Productcontactliners(orrawmaterial/work-in-progresscontactliners)shallbeappropriatelyc

3、olouredandofsufficientgaugetopreventaccidentalcontaminationwhereappropriate5.4.5Wherepackagingmaterialsposeaproductsafetyrisk,specialhandlingproceduresshallbeinplacetopreventproductcontamination5.5ProductInspectionandLaboratoryTestingThecompanyshallundertakeorsubcontractinspec

4、tionandanalyseswhicharecriticalconfirmproductsafetylegalityandquality,usingappropriateprocedures,facilitiesandstandardswhichpreventrisktoproductsafety.5.5.1ProductInspectionRequirements5.5.1.1Basedonriskassessment,testingandinspectionschedulesshallbeestablishedtoensurespecifie

5、dproductrequirementsaremet.Inspectionandtestingmethodsandfrequencyshallbedocumented.5.5.1.2Testandinspectionresultsshallberecordedandreviewedregularlytoidentifytrends.Appropriateactionsshallbeimplementedpromptlytoaddressanyunsatisfactoryresultsorwheretrendsindicateunsatisfacto

6、ryresults.5.5.1.3wherevalidationoffinishedproductqualityattributesisrequired,organoleptictestsshallbecarriedoutregularlyinaccordancewithspecificationsandshallberecorded.Thecompanyshallensurethatasystemofongoingshelflifeassessmentisinplace.thisshallincludemicrobiologicalandsens

7、oryanalysisaswellasrelevantchemicalfactorssuchaspHandaw.Recordsandresultsfromshelflifetestsshallvalidatetheminimumshelflifeperiodindicatedontheproduct.5.5.2LaboratoryTestingRequirements5.5.2.1Pathogentestingshallbesubcontractedtoanexternallaboratoryor,whereconductedinternally,

8、thelaboratoryfacilityshallberemotefromthemanufacturingsite.5.