USP-食品补充剂成分认证计划参与者手册

ManualforParticipantsCertifyingIngredientQualityfortheDietarySupplementIndustryUSPDietaryIngredientVerificationProgramUSPDietaryIngredientVerificationProgramUNITEDSTATESPHARMACOPEIADietaryIngredientVerificationProgramManualforParticipantsCopyright2007-2011TheUnitedStatesPharmacopeialConvention.Allrightsreserved.V.2.0.January2011iNOTICEThismanualprovidesinformationtodietaryingredientmanufacturerswhowishtoparticipateintheUnitedStatesPharmacopeia’sDietaryIngredientVerificationProgram(USPDietaryIngredientVP,USPDIVPor“Program”).TheProgramisdesignedtoassistparticipantsinassuringtheircustomers–dietarysupplement1manufacturersorotherfinishedproductmanufacturers–thatthemanufacturedingredientisproducedinaccordancewithGoodManufacturingPractices(asdefinedinthismanual)andtheparticipant’sotherqualitycontrolsandsystemscomplywiththeingredientlabel,andmeetotherProgramrequirements.USPconsidersthistobeacooperativeeffortbetweenUSPandparticipants.USPwelcomessuggestionsforimprovementstotheProgram.ParticipantswhomeettherequirementsofthisProgramwillreceivepermissiontouseaspecialUSPCertificationMarkinconjunctionwithacertificateofanalysisorsimilardocument.Barringsafetyconcernsorotherspecialcircumstances(seesection18APPEALS),USPmaintainstheconfidentialityofinformationgainedthroughtheverificationprocessinaccordancewiththeprovisionsoftheProgramLicenseAgreement.1USPunderstandsthatthetermdietarysupplementintheUShasdifferentmeaningsinothercountries.Non-UStermsinclude:botanicals,herbals,herbalmedicines,nutraceuticals,foodsupplementsandnaturalhealthproducts.UNITEDSTATESPHARMACOPEIADietaryIngredientVerificationProgramManualforParticipantsCopyright2007-2011TheUnitedStatesPharmacopeialConvention.Allrightsreserved.V.2.0.January2011iiTABLEOFCONTENTSNOTICE................................................................................................................................i 1. OVERVIEW.........................................................................................................................1 2. CRITERIAFORPARTICIPATION......................................................................................3 3. REQUIREDPROCESSANDSUBMISSIONS....................................................................4 4. PROCESSFLOWCHART..................................................................................................7 5. DIETARYINGREDIENTACCEPTANCECRITERIA..........................................................8 6. EVALUATIONOFINITIALAUDITDOCUMENTATION....................................................10 7. ON-SITEAUDITCRITERIA..............................................................................................12 8. SAMPLINGANDSUBMISSIONOFDIETARYINGREDIENTDOCUMENTATION.........15 9. EVALUATIONOFCHEMISTRY,MANUFACTURINGANDCONTROLSDOCUMENTATION..........................................................................................................16 10. TESTINGOFDIETARYINGREDIENTSAMPLES...........................................................21 11. SPECIFICATIONSFORRAWMATERIALAND/ORDIETARYINGREDIENT.................22 12. USPDIETARYINGREDIENTVERIFICATIONPROGRAMREPORTOFFINDINGS......25 13. ISSUANCEANDUSEOFTHEUSPCERTIFICATIONMARK.........................................27 14. NEEDFORRE-EVALUATIONANDRENEWALOFVERIFICATION..............................29 15. PARTICIPANT’SINTERNALAUDITS,USPAUDITS,ANDANNUALREPORTS............35 16. POST-VERIFICATIONSURVEILLANCE..........................................................................36 17. APPEALS..........................................................................................................................37 18. GLOSSARY......................................................................................................................40 19. FORMSANDCHECKLISTS.............................................................................................44 20. LegalNotices....................................................................................................................73 UNITEDSTATESPHARMACOPEIADietaryIngredientVerificationProgramManualforParticipants1Copyright2007-2011TheUnitedStatesPharmacopeialConvention.Allrightsreserved.V.2.0January20111.OVERVIEWTheUSP’sDietaryIngredientVerificationProgram(USPDietaryIngredientVPor“Program”)isoneofseveralpublichealthprogramsoftheUnitedStatesPharmacopeia(USP).Participationisvoluntaryandopentoparticipantsmanufacturingdietaryingredientsforuseindietarysupplementsandotherfinishedproducts.USPusesUSdefinitionsofdietaryingredientstoincludevitamins,minerals,aminoacids,botanicalextractsandnon-botanicals,andothernon-botanicalsubstancesthatareusedinthemanufactureofdietarysupplementproducts.TheProgramcoversdietaryingredientsusedinthemanufactureofdietarysupplementsandotherfinishedproducts.TheProgramincludes:ƒEvaluationofparticipants’qualitysystemsthroughauditofeachmanufacturingsiteforcompliancewithGoodManufacturingPractices(e.g.,ICHQ7GoodManufacturingPracticeGuideforActivePharmaceuticalIngredients)ƒReviewofmanufactur