警告信精选W194W156(中英文版).pdfVIP

FDAWarningLetters,Form483Observations,EstablishmentInspectionReports FDA警告信，483缺陷表，检查报告 Important:Warning lettersshoul be interprete inthe context of full content.Just lookingat extracts may be misleading. An sometimes they include goo advice from the FDA not mentione intheextracts. 重要的警告信可能会用完整的上下文内容来解释。只看摘要可能会导致误解。有时候完整的 内容会包含摘要中没有包括的来自FDA的建议。 W-194 Keywords:GLP,rawdata,reasonforchange,responsibilitiesofQAU,integrityofstudydata 关键词：GLP, 原始数据，变更理由，质保责任，研究数据的完整性 • Primary Deviations: Incompletestudy records, no reasonfor changeof study records,QAU notfulfille itsresponsibilities,ra