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    SOP For Handling of Out of Trend (OOT)

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    Mubarak Patel
    This standard operating procedure outlines the process for handling out of trend (OOT) results observed during laboratory testing of pharmaceutical samples. When an OOT result is observed, the analyst must notify the quality control manager to conduct a preliminary investigation. The investigation may determine laboratory error or require reanalysis. The quality assurance manager makes the final decision regarding OOT results and their implications.

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    © All Rights Reserved

    SOP For Handling of Out of Trend (OOT)

    Uploaded by

    Mubarak Patel
    629 views3 pages
    This standard operating procedure outlines the process for handling out of trend (OOT) results observed during laboratory testing of pharmaceutical samples. When an OOT result is observed, the analyst must notify the quality control manager to conduct a preliminary investigation. The investigation may determine laboratory error or require reanalysis. The quality assurance manager makes the final decision regarding OOT results and their implications.

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    SOP for Handling of Out of Trend (OOT)

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    This standard operating procedure outlines the process for handling out of trend (OOT) results observed during laboratory testing of pharmaceutical samples. When an OOT result is observed, the analyst must notify the quality control manager to conduct a preliminary investigation. The investigation may determine laboratory error or require reanalysis. The quality assurance manager makes the final decision regarding OOT results and their implications.

    Copyright:

    © All Rights Reserved
    629 views3 pages

    SOP For Handling of Out of Trend (OOT)

    Uploaded by

    Mubarak Patel
    This standard operating procedure outlines the process for handling out of trend (OOT) results observed during laboratory testing of pharmaceutical samples. When an OOT result is observed, the analyst must notify the quality control manager to conduct a preliminary investigation. The investigation may determine laboratory error or require reanalysis. The quality assurance manager makes the final decision regarding OOT results and their implications.

    Copyright:

    © All Rights Reserved
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    The key takeaways are that the SOP outlines the procedure for investigating out of trend results observed during laboratory testing and determining the appropriate actions. It defines responsibilities for notifying managers and reviewing investigation reports. The SOP also provides forms to record details of any out of trend occurrences.

    The objective of the SOP is to lay down the procedure for conducting an investigation of Out of trend (OOT) results observed during laboratory testing of samples.

    The SOP outlines that it is the responsibility of QC Executives to notify the QC Manager about the OOT result. The QC Manager is accountable for implementing the SOP. The QA Manager is responsible for reviewing and closing the Investigation Report.

    7/18/22, 8:32 PM SOP for Handling of Out of Trend (OOT)

    SOP for Handling of Out of Trend (OOT)


    pharmaceuticalsky.com/2020/06/sop-for-handling-of-out-of-trend-oot.html

    OBJECTIVE:
    To lay down the procedure for conducting an investigation of Out of trend (OOT) results
    observed during laboratory testing of samples. 

    SCOPE:
    This SOP is applicable to the out of trend results observed in the analysis of raw materials,
    packing materials, finished product, in-process samples, environmental monitoring results,
    water results and stability samples with respect to the previous stability test points.

    RESPONSIBILITY:
    It is the responsibility of QC Executives to
    notify the QC Manager about the OOT result. 
    QC Manager shall be accountable for
    implementation of this SOP. 
    QA Manager shall review and Closing of
    Investigation Report. 

    PROCEDURE:
    Out of trend result shall be determined on the
    basis of the data of previous batches or
    previous analytical data or aberrant data
    observed during analysis. The result may be
    within the specification but not in the trend. 
    While performing the analysis, if any OOT is observed, then the analyst shall
    immediately inform the QC Manager to conduct the preliminary investigation along
    with the analyst of the OOT observation as per Section – I of Annexure - I (OOT
    Investigation Form). 
    Executive shall store the sample and standard preparations and any other preparations
    used during the analysis until the investigation is completed. 
    Make the necessary entries in the OOT log (Annexure-II) by assigning the OOT No. as
    follows: 

           OT/XX/ YYY 
         Where, 
            OOT: Out of Trend 
            XX: Last two digits of the current year (e.g. for 2018 mention 18) 
            YYY: Sequential number (e.g. 001,002 ……) 

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    7/18/22, 8:32 PM SOP for Handling of Out of Trend (OOT)

    During the above investigation, if the cause of OOT result is identified as laboratory
    error QC Manager conclude on it and repeat analysis shall be carried out and reported. 
    The same analyst shall repeat the test with a fresh sample and fresh standard
    preparation (if required) with due care to omit the errors identified. 
    In case if the cause of OOT result is not identified as laboratory error then QC manager
    shall recommend for reanalysis to confirm the OOT results. If the results of repeat
    analysis are similar to a previous analysis the OOT results are valid and the same shall
    be informed to the concerned departments.
     
    The analyst shall record the re-analysis results in the datasheet. 
    If the reanalysis results are within the trend and observations are not aberrant, then
    the initial analysis shall be investigated for the cause of OOT and report the repeat
    analysis results. 
    If the cause of OOT results is not identified, and if the results of re-analysis are same as
    the previous analysis then the results obtained during the first analysis shall be
    reported. 
    If the test result is out of trend, it shall be concluded that the material/product is not
    meeting the trends and the final decision for acceptance of material/product shall be
    taken by QA Manager. 
    In case of raw and packing material: QC manager shall review the OOT results and
    forward the same to QA manager for investigation and prevent the recurrence of such
    incident in the future supplies.
     
    In case of Finished Products: QC manager shall review the OOT results and forward the
    same to QA and Production for information and investigation. A final decision will be
    taken by QA manager based on the investigation report. 
    In case of Stability studies: OOT investigations to be carried out and if required
    analysis can be performed using the samples of the previous stability test point. A final
    decision will be taken by the QA manager based on the investigation report in
    coordination with Production. 

    ABBREVIATIONS: 
    QC – Quality Control 
    OOT – Out of Trend 
    SOP – Standard Operating Procedure 
    QA – Quality Assurance 

    ATTACHMENTS: 
    Attachments I: OOT Investigation Form 
    Attachments II: Logbook OOT Test Result

    Click an Image below is provided (as is) to download Annexure. 

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    7/18/22, 8:32 PM SOP for Handling of Out of Trend (OOT)

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