原始结果和调查复测的结果都报告吗？
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想问一下：如果对原进样小瓶复测、原容量瓶、上一级储备液重新稀释、使用原样品重新配制样品溶液，这4个结果都与原始结果一致。那确认是OOS结果，原始结果有效，报告所有检测结果(原始结果和调查复测的4个结果都报告)吗？

2023-11-23 08:45 就抠呗     
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原始结果在COA中报告，其余结果在调查报告中报告，都作为放行时参考审核的依据。

FDA Investigating Out-of-Specification (OOS) Test Results for Pharmaceutical Production - Level 2 revision Guidance for Industry 1

https://lib.shilinx.com/wiki/index.php?title=FDA_Investigating_Out-of-Specification_OOS_Test_Results_for_Pharmaceutical_Production-Level_2_revision_Final_202205&searchText=OOS

A. Interpretation of Investigation Results

The QU is responsible for interpreting the results of the investigation. An initial OOS result does not necessarily mean the subject batch fails and must be rejected. The OOS result should be investigated, and the findings of the investigation, including retest results, should be interpreted to evaluate the batch and reach a decision regarding release or rejection (§ 211.165).

2023-11-25 09:33 匿名     
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