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1、<1225>VALIDATIONOFCOMPENDIALPROCEDURES药典规程的验证Testproceduresforassessmentofthequalitylevelsofpharmaceuticalarticlesaresubjecttovariousrequirements.AccordingtoSection501oftheFederalFood,Drug,andCosmeticAct,assaysandspecificationsinmonographsoftheUnitedStatesPharmacopeiaandtheNationalFormularyc
2、onstitutelegalstandards.TheCurrentGoodManufacturingPracticeregulations[21CFR211.194(a)]requirethattestmethods,whichareusedforassessingcomplianceofpharmaceuticalarticleswithestablishedspecifications,mustmeetproperstandardsofaccuracyandreliability.Also,accordingtotheseregulations[21CFR211.194(
3、a)(2)],usersofanalyticalmethodsdescribedinUSP-NFarenotrequiredtovalidatetheaccuracyandreliabilityofthesemethods,butmerelyverifytheirsuitabilityunderactualconditionsofuse.RecognizingthelegalstatusofUSPandNFstandards,itisessential,therefore,thatproposalforadoptionofneworrevisedcompendialanalyt
4、icalproceduresbesupportedbysufficientlaboratorydatatodocumenttheirvalidity.用于评价药物质量水平的测试规程受到多种要求的影响。根据联邦食品、药物、化妆品法案501款,在美国药典和国家处方集的各论中的含量测定和质量标准构成了法定标准。现行药品优良生产规范【21CFR211.194(a)】要求,用于评价药物与既有质量标准之间的符合性的分析规程必须在准确度和可靠性方面达到适当的标准。并且根据这些法规【21CFR211.194(a)(2)】,在USP-NF中描述的分析规程的使用者无需验证这些规程的准确度和可靠性,
5、而仅需确认其在实际使用条件下的适用性。认识到USP和NF标准的法律地位,因此,提议采纳新的或更改过的药典分析规程时,以充分的实验室数据作为支持,以记录其有效性,成为基本要求。Thetextofthisinformationchapterharmonizes,totheextentpossible,withtheTripartiteInternationalConferenceonHarmonization(ICH)documentsValidationofAnalyticalProceduresandtheMethodologyextensiontext,whicharecon
6、cernedwithanalyticalproceduresincludedaspartofregistrationapplicationssubmittedwithintheEC,Japan,andtheUSA.本信息章节的内容尽可能地与三方国际协调会议(ICH)文件分析规程的验证和方法学的延伸内容保持一致,ICH的内容关注的是作为在欧盟、日本、美国提交注册申请的一部分的分析规程。SUBMISSIONSTOTHECOMPENDIA向药典提交的文件Submissionstothecompendiaforneworrevisedanalyticalproceduresshould
7、containsufficientinformationtoenablemembersoftheUSPCouncilofExpertsanditsExpertCommitteestoevaluatetherelativemeritofproposedprocedures.Inmostcases,evaluationsinvolveassessmentoftheclarityandcompletenessofthedescriptionoftheanalyticalprocedures,det