符合2010版GMP要求的过滤工艺溶出物-析出物验证

符合2010版GMP要求的过滤工艺溶出物/析出物验证作者：蒋震，董巍，洪海燕，JIANGZhen，DONGWei，HONGHaiyan作者单位：颇尔中国生命科学部,上海,201203刊名：中国医药工业杂志英文刊名：ChineseJournalofPharmaceuticals年，卷(期)：2012,43(6)参考文献(7条)1.Bio-ProcessSystemAllianceExtractablesandLeachablesSubcommitteeRecommendationsforextractablesandleachablestesting2007(11)2.LevyRV;JornitzMWTypesoffiltration20063.WakankarAA;WangYJ;Canova-DavisEOnDevelopingaprocessforconductingextractableleachableassessmentofcomponentsusedforstorageofbiopharmaceuticals2010(05)4.DingW;MartinJImplementingsingle-usetechnologyinbiopharmaceuticalmanufacturing.Anapproachtoextratables/leachablesstudies.Partone.Connectorsandfilter2008(09)5.DingW;MartinJImplementingsingle-usetechnologyinbiopharmaceuticalmanufacturing.Anapproachtoextratables/leachablesstudies.Parttwo.Tubingandbiocontainers2009(05)6.Safetythresholdsandbestpracticesforextractablesandleachablesinorallyinhaledandnasaldrugproducts,productqualityresearchinstitute(PQRI)20067.ELSIEExtractablesandleachablessafetyinformationexchange本文链接：