-While OOS guidance is not directly intended for bioassay analysis, it can be used as a starting point for the investigation. Compendia such as the BP; PhEur and USP, provide guidance on outliers for these types of analysis. Home Slide 25 Crown copyright Phase II Investigation - Unknown ...
OOS(OOT)结果La阶段调查Ib阶段调查II阶段调查III阶段调查 批处置 LaboratoryAnalysis Investigationsof"OutofSpecification(OOS)/OutofTrend(OOT)/Atypicalresults"havetobedoneincasesof:•Batchreleasetestingandtestingofstartingmaterials.•In-ProcessControltesting:ifdataisusedforbatchcalculations/decisionsandifinadossier ...
3月30日FDA给美国本土企业Tarmac Products,Inc.的警告信中第二个缺陷就是OOS调查不充分。 参考文献: 1.Guidance forIndustry Investigating Out-of-Specification (OOS) Test Results forPharmaceutical Production 2006 2.https://www.gov.uk/government/uploads/system/uploads/attachment_data/file/678256/MHRA_OOS_...
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