VALIDATIONOFCOMPENDIALPROCEDURES药典方法的验证Testproceduresforassessmentofthequalitylevelsofpharmaceuticalarticlesaresubjecttovariousrequirements.AccordingtoSection501oftheFederalFood,Drug,andCosmeticAct,assaysandspecificationsinmonographsoftheUnitedStatesPharmacopeiaandtheNationalFormularyconstitutelegalstandards.TheCurrentGoodManufacturingPracticeregulations[21CFR211.194(a)]requirethattestmethods,whichareusedforassessingcomplianceofpharmaceuticalarticleswithestablishedspecifications,mustmeetproperstandardsofaccuracyandreliability.Also,accordingtotheseregulations[21CFR211.194(a)(2)],usersofanalyticalmethodsdescribedinUSP–NFarenotrequiredtovalidatetheaccuracyandreliabilityofthesemethods,butmerelyverifytheirsuitabilityunderactualconditionsofuse.RecognizingthelegalstatusofUSPandNFstandards,itisessential,therefore,thatproposalsforadoptionofneworrevisedcompendialanalyticalproceduresbesupportedbysufficientlaboratorydatatodocumenttheirvalidity.用于评估药品质量的检验方法需要满足不同的要求。根据联邦食品，药品，和化妆品法案501章，美国药典和国家处方专题论文里的试验和规范构成了法律标准。CGMP法规[21CFR211.194(a)]要求：用于评估药品满足已建立的规范的检验方法必须满足准确、可靠、适当的标准。此外，根据法规21CFR211.194(a)(2)，USP-NF中叙述的分析方法的使用者不需要验证这些方法的准确度和可信度，仅仅需要确认在实际使用条件下的适用性。考虑到USP和NF的法律地位，采用新的或修改后的药典分析方法的建议，并且这个建议是由充分的实验室数据支持以证明其有效，这是十分必要的。Thetextofthisinformationchapterharmonizes,totheextentpossible,withtheTripartiteInternationalConferenceonHarmonization(ICH)documentsValidationofAnalyticalProceduresandtheMethodologyextensiontext,whichareconcernedwithanalyticalproceduresincludedaspartofregistrationapplicationssubmittedwithintheEC,Japan,andtheUSA.这一章节的内容尽可能地和ICH文献“分析方法的验证和方法学”（文献与包含在EC，日本和美国递交的注册申请中的分析方法相关）协调一致。SUBMISSIONSTOTHECOMPENDIA递交至药典Submissionstothecompendiaforneworrevisedanalyticalprocedures...
