GuidanceforIndustry,InvestigatingOutofSpecification(OOS)TestResultsforPharmaceuticalProduction行业指南:(CDER)September1998CP#..........................................................................................................................2ResponsibilityoftheAnalyst检验员的责任...........................................................................................................一般调查原则....................................................................调查结论......................................................................报告................................................................pliance/DivisionofManufacturingandProductQuality,CenterforDrugEvaluationandResearch(CDER)’,regulations,、产品、质量分部起草,本指南阐明了机构关于评估OOS检验结果的现行的想法。它不会创造或赠与任何人任何权力,也不会约束FDA或公众。如果其他可选择的相接近的指南能满足适用的法令和法规的要求,也可以使用。GUIDANCEFORINDUSTRY1InvestigatingOutofSpecification(OOS)TestResultsforPharmaceuticalProduction行业指南:’scurrentthinkingonhowtoevaluatesuspect,oroutofspecification(OOS),,eptancecriteriaestablishedinnewdrugapplications,pendia,,本指南的目的,OOS结果包括超出了新药申请材料
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