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...
For more information about handling out-of-specification, out-of-trend, or other unexpected results and documentation of your investigations, see FDA’s guidance document Investigating Out-of-Specification (OOS) Test Results for Pharmaceutical Production at https:/...
For more information about handling out-of-specification, out-of-trend, or other unexpected results and documentation of your investigations, see FDA’s guidance document Investigating Out-of-Specification (OOS) Test Results for Pharmaceutical Production at https://www.fda.gov/media/71001/download. ...
For more information about handling out-of-specification, out-of-trend, or other unexpected results and documentation of your investigations, see FDA’s guidance document Investigating Out-of-Specification (OOS) Test Results for Pharmaceutical Production athttps://www.fda.gov/media/71001/download. 有...
9月22日,FDA公布一封针对美国本土企业的警告信。主要的违规项设计OOS调查问题和未能执行工艺验证研究,在此基础上FDA认为该企业的质量部门失效,并存在严重的数据完整性问题。 FDA重点指出,与OOS结果相关的原始数据已被重写,无法查看;公司OOS调查中唯一可用的信息是某检验结果很高,出现OOS。
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 Issues Guidances on Quality Systems, OOS, Cell LinesMcCormick, Douglas
Guidance for Industry Investigating Out of Specification (OOS) Test Results for Pharmaceutical Production DRAFT GUIDANCE This guidance document is being distributed for comment purposes only. Comments and suggestions regarding this draft document should be submitted within 60 days of publication of the ...
Guidance for Industry Investigating Out-of-Specification (OOS)Test Results for Pharmaceutical Production U.S. Department of Health and Human Services Food and Drug Administration Center for Drug Evaluation and Research (CDER)October 2006 Pharmaceutical CGMPs Contains Nonbinding Recommendations ...
? ? Guidance for Industry 行业指南 Investigating Out-of-Specification (OOS) Test Results for Pharmaceutical Production 药品生产中OOS结果的调查 Additional copies are available from: 本文件可自以下途径得到 Office of Training and Communication 培训和交流办公室 Division of Drug Information HFD-240 药品信息...