怎样做好GMP的验证

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1、RiskAnalysisMixer-granulation-dry-mixingtime-granulationliquid;amount,temperature,time-mixingintensity-wetmixingtime-granulationend-point-dryingtemperature-dryingtimeTablets-compressingspeed-compressingforce-loadlevelofblendfeeding-feeding-hardness-friability-weightuniformity-contentunifor

2、mity-disintegrationtime-dissolutionrateCapsules-flowbehaviorofgranules-compactionpressure-fillingspeed-loadlevelofblendfeeding-powderbedlevel-weightuniformity-contentuniformity-dissolutionrateOralliquidmanufacture-stirringtime-typeofstirrer,speed-standingtimeuptofilling-temperatureofvessel

3、jacketforheating-filter(type,retentionrate,etc.)-weight/volumeofcontent-accuracyoffilling-fillingspeed-temperature-pH-viscosity-refractiveindexAccuracy-thismeanstheclosenessbetweentheanalyzedvalueandtheactualvalue.Thistestshouldbedoneinatleastthreeconcentrations,eachrepeatedatleastthreetim

4、es.Recoveryrateshouldbe95%-105%.Precision-thismeanstheclosenessbetweenalltheanalyzedvalues.Eachanalyzedvalueshouldberepeated6times.RSDforchemicalandinstrumentalanalysisshouldbenotgreaterthan1.5%&2.0%respectively.Specificity-thismeansthecapabilityofthemethodtoaccuratelyanalyzetheintendedcom

5、ponentandnotbeinterferedbythepresenceofothercomponentsAnalysislimit-thismeansthatthemethodneedsnotreportthequantitativeresult.Itonlyneedstoreporthigherthanorlowerthancertainvalue.Detectionlimit-thismeansthelowestvalueatwhichthemethodcouldanalyzeordetect.Linearity-thismeansthattherelationsh

6、ipbetweenthereportedvaluesbytheanalyticalmethods,andtheactualparametersofthematerial(e.g.concentrationofcomponentAorsolubilityofproductBetc),islinear.Range-thismeansthevaluesbetweenthehighestandlowestlevels.CleaningvalidationPrinciplesandobjectivesCleaningmethodandprocedureWhichisthemolecu

7、letorepresentresidue?Whichpartofequipmentistorepresentcleanliness?–selectionofthesamplingpointMethodsofmeasuringremainingresidue–selectionofthesamplingmethodDeterminingallowablelevelofresidueCleaningmethodandprocedureGenerally,byrinsing,wipingorcombinationofbo