{"title":"过程能力","authors":"Edward M. Schrock, Henry L. Lefevre","doi":"10.1201/9781003065937-20","DOIUrl":null,"url":null,"abstract":"Process capability is a tool used to formally assess whether pharmaceutical equipment, instruments or processes are fit for purpose with respect to specifications, in-process limits or manufacturer's claims. Process capability methods may seem fraught with complex statistical mathematics, but these can be simplified to reveal core scientific principles.","PeriodicalId":171978,"journal":{"name":"The Good and the Bad News About Quality","volume":"18 1","pages":"0"},"PeriodicalIF":0.0000,"publicationDate":"2020-11-25","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":"7","resultStr":"{\"title\":\"Process Capability\",\"authors\":\"Edward M. Schrock, Henry L. Lefevre\",\"doi\":\"10.1201/9781003065937-20\",\"DOIUrl\":null,\"url\":null,\"abstract\":\"Process capability is a tool used to formally assess whether pharmaceutical equipment, instruments or processes are fit for purpose with respect to specifications, in-process limits or manufacturer's claims. Process capability methods may seem fraught with complex statistical mathematics, but these can be simplified to reveal core scientific principles.\",\"PeriodicalId\":171978,\"journal\":{\"name\":\"The Good and the Bad News About Quality\",\"volume\":\"18 1\",\"pages\":\"0\"},\"PeriodicalIF\":0.0000,\"publicationDate\":\"2020-11-25\",\"publicationTypes\":\"Journal Article\",\"fieldsOfStudy\":null,\"isOpenAccess\":false,\"openAccessPdf\":\"\",\"citationCount\":\"7\",\"resultStr\":null,\"platform\":\"Semanticscholar\",\"paperid\":null,\"PeriodicalName\":\"The Good and the Bad News About Quality\",\"FirstCategoryId\":\"1085\",\"ListUrlMain\":\"https://doi.org/10.1201/9781003065937-20\",\"RegionNum\":0,\"RegionCategory\":null,\"ArticlePicture\":[],\"TitleCN\":null,\"AbstractTextCN\":null,\"PMCID\":null,\"EPubDate\":\"\",\"PubModel\":\"\",\"JCR\":\"\",\"JCRName\":\"\",\"Score\":null,\"Total\":0}","platform":"Semanticscholar","paperid":null,"PeriodicalName":"The Good and the Bad News About Quality","FirstCategoryId":"1085","ListUrlMain":"https://doi.org/10.1201/9781003065937-20","RegionNum":0,"RegionCategory":null,"ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":null,"EPubDate":"","PubModel":"","JCR":"","JCRName":"","Score":null,"Total":0}
Process capability is a tool used to formally assess whether pharmaceutical equipment, instruments or processes are fit for purpose with respect to specifications, in-process limits or manufacturer's claims. Process capability methods may seem fraught with complex statistical mathematics, but these can be simplified to reveal core scientific principles.
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