GWP良好的称量管理规范2017版

GWP®122334454.154.264.374.484.595105.1115.2135.3145.4USP155.5175.61761819GWP®GoodWeighingPractice™2-(OOS)GWP®GWP®GWP®GWP®1.3-1993BarrLabs[1]BarrLabsOOS200610FDAOOS[2]FDA483OOS[3]7Barr20FDAFDA483OOSOOSOOSGMO20111(FSMA)[4]FDAFDA4832.4-(USP)[5][]3141USP41ISOGMPGMPBRCIFSSQFFSSC220006BRC6.3CCP[][]3.5-120000kgOOSOOSOOS4.1[6]0.1mg200g0.1mg0.1mg(RP)(EC)(NL)(SE)1[7]4.1.1kg6-(GUM)[8][9,10]2Uabs=α+β·m4.22mmin=Uabs(mmin)/Areq=(α+β·mmin)/Areq2.[%]=/[mg]U[mg%][g][%]7-Areqmmin=α/(Areq-β)ααsRPkmmin≈α/Areq≈(k/Areq)·sRP2USP410.10%[11]mmin=(k/Areq)·sRP=(2/0.1%)·sRP=2000·sRPUSP1251[12]USP410.29ddsmin=√2·0.29d=0.41d[9,10]USP41[11]4.33200 g1.110g38-2.2100g33.30.41d4.4243.200g0.1mgU_totU_RPU_ECU_NLU_SEk=2(@k=2)[g][%]9-USP12511.2.3.4.5.1%20.5%1%4.2mmin=α·SF/(Areq-β·SF)AreqαβSF4.53USP125110-1002010010020[]/ISO9001:20087.6[]21CFRPart211.68(a),USGMPforPharma[]SQF20006.4.1.11.//45.11-ISO9001GxPUSP2.3.FDA[13]5.1i.ii.iii.54./12-USP1251[][...]SOPUSP1251USP31065.=13-330%5.2i)OIMLASTM220g200gOIMLii)OIMLASTM5%220g10gOIML1.(mpe)1/310%1/3USP412.3.OIMLF2F1E2OIMLMOIMLF2M[14]ASTMASTM4[15]M4.14-5.3a)315%USP415%100%USP1225USP41SOPUSP5%USP415%ISO9001GxPUSP6(W)(1)(a1)(b1)(a)(b)[]15-b)USP12515%250mL90g5[17]USP1251[]c)5.4USPUSP410.10%16-OIML1-2-5ASTM1-2-3-520 mg20 mg5mg45mg–––1-2-5(1-2-3-5)USP41125141[...]125141mmin=2000·sRPSENLEC17-5.5[13]USP12515.618-6.GWP®GWP®19-1.BarrLaboratories,Inc.,812FSupp458(DNJ1993)2.GuidanceforIndustry:Investigatingout-of-specification(OOS)testresultsforpharmaceuticalproduc-tion.:Part1of3:Out-of-SpecificationInvestigationsStillPerplexLabs20112/3=325598564E8C4B3EB736C7159241312D&nm=Browse+Articles&type=Publishing&mod=Publications%3A%3AArticle&mid=D3E3C719D8D44216836DCA4F4144BEC4&AudID=5648A5C28C97462DBBDB309539B820EF&tier=4&id=5640184742864AE9B95AA7887DBB96014.FoodSafetyModernizationAct,PublicLaw111-353–Jan.4,2011,124STAT.3885ff5.GeneralNoticesandRequirements,USPharmacopeiaUSP39–NF34throughSecondSupplement,Rockville,Maryland,2015,Online-Edition6.ReichmuthA.,FritschK.,GoodWeighingPracticesinthePharmaceuticalIndustry–Risk-BasedQualificationandLifeCycleManagementofWeighingSystems,PharmaceuticalEngineering,Volume29,Number6,Tampa,Florida,20097.Nater,R.,Reichmuth,A.,Schwartz,R.,Borys,M.,Zervos,P.,DictionaryofWeighingTerms–AGuidetotheTerminologyofWeighing,Berlin,Heidelberg(D):Springer,2009ISBN:978-3-642-02013-18.EvaluationofMeasurementData–GuidetotheExpressionofUncertaintyinMeasurement(GUM),JCGM100:2008,BureauInternationaldesPoidsetMesures,Sèvres,France,2008ía,2008–NF31throughSecondSupplement,Rockville,Maryland,2013,Online-Edition12.GeneralChapter1251WeighingonanAnalyticalBalance,USPharmacopeiaUSP39–NF34throughSecondSupplement,Rockville,Maryland,2015,Online-Edition13.QuestionsandAnswersonCurrentGoodManufacturingPractices,GoodGuidancePractices,Level2Guidance–Equipment–Part1:Metrologicalandtechnicalrequirements,Paris,2004(2008),StandardSpecificationsforLaboratoryWeightsandPrecisionMassStandards,WestConshohocken,PA,200816.GeneralChapter1225ValidationofCompendialProcedures,USPharmacopeiaUSP36–NF31throughSecondSupplement,Rockville,Maryland,2013,Online-Edition17.Reichmuth,A.,WeighingSmallSamplesonLaboratoryBalances,13thInternationalMetrologyCongress,Lille(F),2007,CD-Collection©04/2013Mettler-ToledoAGGlobalMarComSwitzerland-//589021-64850435021-64853351E-mail:[e-mail]/1112131250519-866420400519-86641991E-mail:[e-mail]-30445092