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1、ReprintedfromPHARMACEUTICALENGINEERINGTHEOFFICIALTECHNICALMAGAZINEOFISPESEPTEMBER/OCTOBER2014,VOL34,NO5©CopyrightISPE2014采用工序能力以确保药品质量byThomasGarcia,PhD,RogerNosal,andKimVukovinsky1Thiscommentaryisinresponsetothesymposiumsummaryreportfeaturedonpages10to23ofth
2、isissue.Positiveaspectsofthereportarepresentedinadditiontoareasrequiringfurtherclarification,theimpactofprocesscapabilityonspecificationlimits,therelationshipbetweenQbDandprocesscapability,andthedesireforregulatoryflexibility.Ingeneral,thiscommentaryisintende
3、dtoconstructivelyprogressthesetopicstowardameaningfuloutcome.1本文是针对刊登在本期第10-23页上的研讨会总结报告做出的评论。除需要进一步澄清之处、工序能力对规格范围的影响、QbD与工序能力之间的关系、监管灵活性的愿望之外，文章还介绍了该报告的积极作用。总之，本篇评论的目标在于建设性地促进这些话题产生有意义的成果。PositiveAspects积极作用Gooddiscussionsoccurredduringthesymposiumdemonstrat
4、inghowprocesscapabilityindicesareusefulmetricsformonitoringdrugproductqualityandprocessrobustness.Themetricsshouldbeconsideredinconjunctionwithotherprocessknowledge,whichcandriveoperationalexcellence.Thisapproachisanintegralpartoftheindustryefforttodeveloprob
5、ustprocessestherebyensuringquality,complianceandreliablesupplyofourproducts.Participantswerecautiousabouttheapplicationofprocesscapabilityindicesduringdrugdevelopment,asdatamayonlybeavailablefromalimitednumberofbatches,anddifferencesinequipment,scale,andopera
6、tingconditionscancauseconfusionintheirinterpretation.Processcapabilityindicesarebestusedduringroutineproduction(Stage3–ContinuedProcessVerification).Theyalsohighlightthatprocessmonitoring,inconjunctionwithscienceenhanceddevelopment(e.g.,QualitybyDesign(QbD))c
7、anresultinfewerbatchreworks,rejects,investigationsandproductrecalls.关于工序能力指数是如何成为监测产品质量和过程稳健性的有用指标的，在研讨会中进行了良好的讨论。该指标应结合其他过程知识进行考虑，以达到卓越的运营。这一方法是行业为建立一个稳健的过程（以确保我们产品的质量、合规性以及供应的稳定性）所做出的努力中不1可或缺的一部分。与会者对于工序能力指数在药品的研发中的使用都很谨慎，因为数据只能从有限的批次中获得，此外设备、规模和操作条件的差异也会导致
8、他们在解释上的混乱。工序能力指数最好在日常生产中使用（第3阶段——持续的工艺验证）。他们也强调了过程监测结合科学促进研发（如质量源于设计（QbD））能减少批次返工、不良品、调查和产品的召回。AreasRequiringFurtherClarification需进一步澄清之处Thereseemstobesomeconfusionregardingthefunctionofp
