8生产和过程控制

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1、8.3ln・processSamplingandControls830WrittenproceduresshouldbeestablishedtomonitortheprogressandcontroltheperformaneeofprocessingstepsthatcausevariabilityinthequalitycharacteristicsofintermediatesandAPIs.In-processcontrolsandtheiracceptancecriteriashouldbedefinedb

2、asedontheinformationgainedduringthedevelopmentalstageorfromhistoricaldata・8.31TheacceptsneecriteriaandtypeandextentoftestingcandependonthenatureoftheintermediateorAPIbeingmanufactured,thereactionorprocessstepbeingconducted,andthedegreetowhichtheprocessintroduces

3、variabilityintheproduct'squality.Lessstringentin-processcontrolsmaybeappropriateinearlyprocessingsteps,whereastightercontrolsmaybeappropriateforlaterprocessingsteps(e.g.,isolationandpurificationsteps).8.32Criticalin-processcontrols(andcriticalprocessmonitoring),

4、includingcontrolpointsandmethods,shouldbestatedinwritingandapprovedbythequalityunit(s).8.33In-processcontrolscanbeperformedbyqualifiedproductiondepartmentpersonnelandtheprocessadjustedwithoutpriorqualityunit(s)approvaliftheadjustmentsaremadewithinpre-established

5、limitsapprovedbythequalityunit(s).Alltestandresultsshouldbefullydocumentedaspartofthebatchrecord.8.34Writtenproceduresshoulddescribethesamplingmethodsforin-processmaterials,intermediates,andAPIs.Samplingplansandproceduresshouldbebasedonscientificallysoundsamplin

6、gpractices.8.35In-processsamplingshouldbeconductedusingproceduresdesignedtopreventcontaminationofthesampledmaterialand8.3工序间的取样和控制8.30应当制定书面程序来监测会造成中间体和原料药质量特性变界的工艺步骤的进程，并控制具生产情况。工序间控制及其接受标准应当根据项目开发阶段或者以往的生产数据来确定。8.31综合考虑所生产中间体和原料药的特性，反应类型，该工序对产品质量影响的程度大小等因素來确定可

7、接受的标准，检测类型和范围。前期牛产的屮间体控制标准町以松一些，越接近成品，中间控制的标准越严（如分离，纯化）。8.32关键的中间控制（和工艺监测），包括控制点和方法，应当卩而规定，并经质量部门批准。8.33中间控制可以山合格的生产部门的人员来进行，阳调节的工艺町以事先未经质量部门批准，只要该调节在由质量部门批准的预先规定的限度以内。所有测试及结果都应当作为批记录的一部分全部归档。8.34应当制定巧面程序，说明中间物料、中间体和原料药的取样方法。取样方案和程序应当基于科学合理的収样实践。8.35工序间取样应当按能防止污

8、染所取的样品、•其它中间体或原料药的程序进行。应当制定保证样品收集后的完整性的程序。otherintermediatesorAPIs.Proceduresshouldbeestablishedtoensuretheintegrityofsamplesaftercollection.8.31Out-of-specification(