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 athttps://www.fda.gov/media/71001/download. 有...
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 at https://www.fda.gov/media/71001/download. ...
For more information about handling failing, out-of-specification, out-of-trend, or other unexpected results and documentation of your investigations, see FDA’s current guidance documentInvestigating Out-of-Specification (OO...
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》...
? ? 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...
Inadequate OOs investigations,OOs调查不充分 Inadequate CAPAs,CAPA(Corrective action and preventive action) 纠正措施和预防措施不充分 某一份相关的警告信如下: 某一家公司忽视了之前所有不合格的检测结果,并且没有提供充分的科学理由来证明原始OOS无效或确定根本原因。相反,该公司用无效和未经验证的测试方法重新取样...
Czabaniuk: FDA has aguidance document for investigating OOS test results, available online. You canfind it and follow it for OOS investigations in the laboratory. Czabaniuk:FDA 有一份用于调查 OOS 测试结果的指导文件,可在线查阅。你可以遵循它进行实验室 OOS 调查。
您的OOS调查结论未能在确定根本原因以及偏差程度和药品影响方面包括足够的严谨性和范围。 For more information about handling failing, out-of-specification, out-of-trend, or other unexpected results and documentation of your investigations, see FDA’s current guidance documentInvestigating Out-of-Specification...