4th Floor马里兰州银泉,20993-0002电话:855-543-3784 或 301-796-3400;传真:301-431-6353电子邮件:druginfo@fda.hhs.govhttps://www.fda.gov/drugs/guidance-compliance-regulatory-information/guidances-drugs美国卫生与公众服务部食品和药品管理局药品评估和研究中心(CDER)2022 年 5 月药品质量/制造标准现行良好...
Investigating Out- of- Specification (OOS) Test Results for Pharmaceutical Production Guidance for Industry 药品生产OOS调查行业指南 (2022年5月) 本文翻译仅供用于学习交流,请勿用于商用 文中翻译内容仅供参考,具体以英文原文为主 U.S.DepartmentofHealthandHumanServices FoodandDrugAdministration CenterforDrug...
For more information about handling OOS results and documentation of your investigations, please refer to the FDA guidance for industry publication Investigating Out-of-Specification at https://www.fda.gov/media/158416/download...
2022 年 5月,FDA 针对药品生产中的偏差 / 超标(out of specification,OOS)发布了行业指南《药品生产中 OOS 检测结果的调查》[5](简称“行业指南”),该行业指南中讨论了如何调查 OOS 结果,从实验室人员职责、实验室调查阶段、可能需要的附加检测、扩大调查范...
855-543-3784 或 301-796-3400;传真:301-431-6353 电子邮件:druginfo@ /drugs/guidance-compliance-regulatory-information/guidances-drugs 美国卫生与公众服务部 食品药品监督管理局 药物评价和研究中心(CDER) 2022 年 5 月 制药质量/生产标准 现行良好生产管理规范(CGMP) 本中文翻译由 DIRTRANS整理并提供,行业...
2022年,FDA的药物评估和研究中心(CDER,Center for Drug Evaluation and Research)发布了调查药品生产的不合格(OOS)测试结果-行业2级修订指南。该指南的目的是提供FDA目前关于如何评估不合格(OOS)测试结果的指导,包括实验室人员的责任、调查的实验室阶段、可能需要的额外测试、何时扩大实验室外的调查,并对所有测试结果进...
(4) result in the same purity.” However, your response does not provide evidence from the out-of-specification (OOS) investigation or formal risk assessment process which led to this conclusion, nor does the response address the root cause for the unacceptable levels of the acetal and acetal...
For more information about handling OOS results and documentation of your investigations, please refer to the FDA guidance for industry publication Investigating Out-of-Specification at https://www.fda.gov/media/158416/download 有关处理 OOS 结果和调查文件的更多信息,请参阅 FDA 行业出版物《超标调查》...
FDA Guidance for industry “Investigating Out-of-specification (OOS) Test results for Pharmaceutical Production” ●FDA《药物质量控制实验室检查指南》中第5章节 Guide to Inspection of Pharmaceutical Quality Control Labs (section 5) ●FDA 211CFR制剂成品的cGMP中关于OOS的要求 ●FDA 药品生产中 OOS 检...
当OOS调查完成时,应提交后续FAR。 参考来源: Investigating Out-of-Specification(OOS)Test Results for Pharmaceutical Production Guidance for Industry.U.S.Department of Health and Human Services Food and Drug Administration Center for Drug Evaluation and Research(CDER).May 2022...