《警告信精选W194-W156（中英文版）》.docxVIP

FDA Warning Letters, Form 483 Observations, Establishment Inspection Reports FDA警告信，483缺陷表，检查报告 Important: Warning letters should be interpreted in the context of full content. Just looking at extracts may be misleading. And sometimes they include good advice from the FDA not mentioned in the extracts. 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, raw data, reason for change, responsibilities of QAU, integrity of study data 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: Incomplete study records, no reason for change of study records, QAU not fulfilled its responsibilities, raw data, no assurance of the quality and integrity of study report, no final study report, no or inadequate testing and calibration of equipment ? 主要错误：研究数据不完全，没有理由地改变研究记录，质保未???行职责，原始数据，研究报告的质量和完整性没有保证，没有最终研究报告，检测和仪器检验没有或不够。 ? Examples: - Failure of the study director to assure that all experimental data were accurately recorded and verified and document the reason for any change in the entries - For study xxx your study director failed to assure that dosing were accurately recorded to confirm that study animals received protocol-specified doses of the vehicle. - Failure of QAU to assure that reported results in the final study report accurately reflected the raw data - Failure of QAU to maintain written and properly signed records of each periodic inspection - Failure to identify the test and control articles with appropriate characteristics in the final report - Failure to adequately test, calibrate, and/or standardize all equipment used the generation, measurement and assessment of data ? 事例： 研究主管未能保证所有的实验数据被准确记录，也未能确认任何条目的变更理由并记录。 为研究xxx，你们的研究主管未能保证准确记录剂量以确保试验动物接受研究草案中规定的剂量 质保未能保证最终研究报告中的结果准确反映原始数据 质保未能在阶段性的检查中持续填写记录并适当签名 在最终研究报告中没有用合适的特定的格式来鉴别测试和控制内容 没有对产生，测量及评估数据的设备进行足够的测试，校准和/或标准化 W-193 Keywords: Batch records, method validation, cleaning validation, equipment calibration 关键词：批记录，方法验证，清洁验证，设备校准 ? Primary Deviations: Incomplete batch r