USP40 1226 药典的确认中英文对照

1226VERIFICATIONOFCOMPENDIALPROCEDURES药典方法的确认Theintentofthisgeneralinformationchapteristoprovidegeneralinformationontheverificationofcompendialproceduresthatarebeingperformedforthefirsttimetoyieldacceptableresultsutilizingthepersonnel,equipment,andreagentsavailable.此章节的意图是对药典方法的确认提供基本资料，使用人员，设备和试剂使第一次进行运用药典方法以产生可接受的结果。Thischapterisnotintendedforretroactiveapplicationtoalreadysuccessfullyestablishedlaboratoryprocedures.ThechapterValidationofCompendialProcedures1225providesgeneralinformationoncharacteristicsthatshouldbeconsideredforvarioustestcategoriesandonthedocumentationthatshouldaccompanyanalyticalproceduressubmittedforinclusioninUSP–NF.Verificationconsistsofassessingselectedanalyticalperformancecharacteristics,suchasthosethataredescribedinchapter1225togenerateappropriate,relevantdataratherthanrepeatingthevalidationprocess.此章节并不旨在对已经成功建立的实验室方法进行回顾性运用。章节〈1225〉药典方法的验证对各种不同检测类别需要考虑的特征以及伴随分析方法的文件给出了基本资料。确认包括评估选择的分析性能特征，在〈1225〉叙述，以产生相关的数据而不是重复验证过程。Usersofcompendialanalyticalproceduresarenotrequiredtovalidatetheseprocedureswhenfirstusedintheirlaboratories,butdocumentedevidenceofsuitabilityshouldbeestablishedunderactualconditionsofuse.IntheUnitedStates,thisrequirementisestablishedin21CFR211.194(a)(2)ofthecurrentGoodManufacturingPracticeregulations,whichstatesthatthe“suitabilityofalltestingmethodsusedshallbeverifiedunderactualconditionsofuse.”不要求药典分析方法的使用者验证实验室第一次使用的方法，但需要具备在实际使用条件下的适用性证明文件。在美国，此要求确立在CGMP21CFR211.194(a)(2)中，其说明了在实际使用条件下所有使用的的检测方法的适用性应确认。VerificationofmicrobiologicalproceduresisnotcoveredinthischapterbecauseitiscoveredinUSPgeneralchaptersAntimicrobialEffectiveness51,MicrobiologicalExaminationofNonsterileProducts:MicrobialEnumerationTests61,MicrobiologicalExaminationofNonsterileProducts:TestsforSpecifiedMicroorganisms62,SterilityTests71,andValidationofMicrobialRecoveryfromPharmacopeialArticles1227.此章节，不包括微生物方法的确认。因为微生物检测方法包含在抗菌效果51、有菌产品的微生物检测：微生物枚举测试61、有菌产品的微生物检测：特定微生物的检测62、无菌检查71、微生物复苏验证1227VERIFICATIONPROCESS确认的过程Theverificationprocessforcompendialtestproceduresistheassessmentofwhethertheprocedurecanbeusedforitsintendedpurpose,undertheactualconditionsofuseforaspecifieddrugsubstanceand/ordrugproductmatrix.药典检测方法的确认过程是评估方法是否可用于其预期的目的,在实际条件下使用指定的药用物质和/或药物产品的矩阵。Usersshouldhavetheappropriateexperience,knowledge,andtrainingtounderstandandbeabletoperformthecompendialproceduresaswritten.Verificationshouldbeconductedbytheusersuchthattheresultswillprovideconfidencethatthecompendialprocedurewillperformsuitablyasintended.使用者应有适当的经验、知识和培训来了解和能够演示药典方法。使用者所做的确认，应是提供了证据：能够证明药典方法能够如预期一样顺利演示。Iftheverificationofthecompendialprocedureisnotsuccessful,andassistancefromUSPstaffhasnotresolvedtheproblem,itmaybeconcludedthattheproceduremaynotbesuitableforusewiththearticlebeingtestedinthatlaboratory.ItmaythenbenecessarytodevelopandvalidateanalternateprocedureasallowedintheGeneralNotices.ThealternateproceduremaybesubmittedtoUSP,alongwiththeappropriatedata,tosupportaproposalforinclusionorreplacementofthecurrentcompendialprocedure.如果药典方法的确认不成功，以及来自USP职员的帮助未能解决问题，可以得出结论方法不适用。有必要开发和验证替代的方法。替代的方法可以递交至USP，附上适当的数据，以支持包括或取代当前药典方法的建议。VERIFICATIONREQUIREMENTS确认的要求Verificationrequirementsshouldbebasedonanassessmentofthecomplexityofboththeprocedureandthematerialtowhichtheprocedureisapplied.确认要求应基于方法和方法所分析的物质的复杂性。Althoughcompleterevalidationofacompendialmethodisnotrequiredtoverifythesuitabilityofaprocedureunderactualconditionsofuse,someoftheanalyticalperformancecharacteristicslistedinchapter1225,Table2,maybeusedfortheverificationprocess.尽管在实际使用条件下，不要求对药典方法的进行完整再验证来确认方法的适用性，一些在1226中列出的分析性能参数（表格2），可用于确认的过程。Onlythosecharacteristicsthatareconsideredtobeappropriatefortheverificationoftheparticularmethodneedtobeevaluated.Theprocessofaccessingthesuitabilityofacompendialanalyticaltestprocedureundertheconditionsofaactualusemayormaynotrequireactuallaboratoryperformanceofeachanalyticalperformancecharacteristic.Thedegreeandextentoftheverificationprocessmaydependontheleveloftrainingandexperienceoftheuser,onthetypeofprocedureanditsassociatedequipmentorinstrumentation,onthespecificproceduralsteps,andonwhicharticle(s)arebeingtested.那些被认为是适用于特定方法确认的参数需要评估。评估在实际使用条件下药典分析检测方法使用的过程可能需要也可能，也可能不需要实际实验室性能的分析性能特征。确认过程的深度和广度取决于培训水平和使用者使用此种方法和使用相关设备或仪器，对特定方法步骤，对检测何种物质的经验。VerificationshouldassesswhetherthecompendialAsanexample,anassessmentofspecificityisakeyparameterinverifyingthatacompendialprocedureissuitableforuseinassayingdrugsubstancesanddrugproducts.Forinstance,acceptablespecificityforachromatographicmethodmaybeverifiedbyconformancewithsystemsuitabilityresolutionrequirements(ifspecifiedinthemethod).例如，专属性的评估是确认药典方法适用于含量测定原料药和制剂的关键参数。例如，色谱方法的可接受的专属性可以通过符合系统适应性分离度要求来确认（如在方法中指明）。However,drugsubstancesfromdifferentsuppliersmayhavedifferentimpurityprofilesthatarenotaddressedbythecompendialtestprocedure.Similarly,theexcipientsinadrugproductcanvarywidelyamongmanufacturersandmayhavethepotentialtodirectlyinterferewiththeprocedureorcausetheformationofimpuritiesthatarenotaddressedbythecompendialprocedure.Inaddition,drugproductscontainingdifferentexci