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    OOT NW

    Uploaded by

    Sagar Chavan
    This standard operating procedure outlines the process for addressing out of trend (OOT) results at Sun Moon Pharmaceuticals Pvt. Ltd. The procedure defines OOT cases, responsibilities of quality control, production, and quality assurance staff in investigating OOT results, and requirements for documenting investigations and observations in an annual product quality review.

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    © All Rights Reserved
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    OOT NW

    Uploaded by

    Sagar Chavan
    120 views2 pages
    This standard operating procedure outlines the process for addressing out of trend (OOT) results at Sun Moon Pharmaceuticals Pvt. Ltd. The procedure defines OOT cases, responsibilities of quality control, production, and quality assurance staff in investigating OOT results, and requirements for documenting investigations and observations in an annual product quality review.

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    OOT-nw

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    This standard operating procedure outlines the process for addressing out of trend (OOT) results at Sun Moon Pharmaceuticals Pvt. Ltd. The procedure defines OOT cases, responsibilities of quality control, production, and quality assurance staff in investigating OOT results, and requirements for documenting investigations and observations in an annual product quality review.

    Copyright:

    © All Rights Reserved
    Download as DOC, PDF, TXT or read online from Scribd
    Download as doc, pdf, or txt
    120 views2 pages

    OOT NW

    Uploaded by

    Sagar Chavan
    This standard operating procedure outlines the process for addressing out of trend (OOT) results at Sun Moon Pharmaceuticals Pvt. Ltd. The procedure defines OOT cases, responsibilities of quality control, production, and quality assurance staff in investigating OOT results, and requirements for documenting investigations and observations in an annual product quality review.

    Copyright:

    © All Rights Reserved
    Download as DOC, PDF, TXT or read online from Scribd
    Download as doc, pdf, or txt
    of 2

    SUN MOON PHARMACEUTICALS PVT. LTD.

    Plot No. N-65, M.I.D.C. Tarapur Boisar, Dist. Palghar, Maharashtra-401 506.
    STANDARD OPERATING PROCEDURE
    TITLE: OUT OF TRENDS
    Department : Quality Assurance SOP No. : SOP/QA/009
    Effective Date : Rev. No. : 00
    Review Date : Supersedes : NA
    Copy No. : Page No. : 1 of 2
    Prepared By Reviewed By Approved By
    Sign. with
    Date.

    1.0 OBJECTIVE:

    To lay down the procedure to address the Out of Trends (OOT) Results at Sun Moon Pharmaceuticals
    Pvt. Ltd.

    2.0 SCOPE:

    Procedure is applicable for the manufacturing facility of the Sun Moon Pharmaceuticals Pvt. Ltd.

    3.0 RESPONSIBILITY:

    In-charge – QC/ Designee-QC : Monitoring the results and raising OOT results.

    Manager/Incharge/Designee-QC/Production/Maintenance: Investigate the OOT.

    Manager – QA/Designee: Investigation and finalizing the root cause.

    4.0 PRECAUTIONS:

    NA

    5.0 PROCEDURE:

    1. OOT investigation will be carried out for the following cases,


    a. If yield of any stage in product is varied by 10% from its standard output.
    b. If Water analysis Microbial count is more than average results of CFU per mL and showing a
    very high Microbial count.
    c. If Powder Processing area’s results of the settling plates analysis is higher than average
    value.
    d. If the microbial contamination in the micro lab by settling plate is more than above average.

    2. If OOT is with respect to the Yield, detail investigation shall be carried out.
    3. If OOT is with respect to the Microbial contamination than area shall be cleaned with appropriate
    method and the area Shall be fumigated.
    SOP/QA/001-F01.00 The document is covered under IPR of Sun Moon Pharmaceuticals Pvt. Ltd. and should not be reproduced without authorization.
    SUN MOON PHARMACEUTICALS PVT. LTD.
    Plot No. N-65, M.I.D.C. Tarapur Boisar, Dist. Palghar, Maharashtra-401 506.
    STANDARD OPERATING PROCEDURE
    TITLE: OUT OF TRENDS
    Department : Quality Assurance SOP No. : SOP/QA/009
    Effective Date : Rev. No. : 00
    Review Date : Supersedes : NA
    Copy No. : Page No. : 2 of 2
    Prepared By Reviewed By Approved By
    Sign. with
    Date.

    4. Any observation of the OOT during the year shall be captured in the annual product quality review.
    (APQR).

    6.0 LIST OF ANNEXURES / ATTACHMENTS:

    NA

    7.0 ABBREVIATIONS:

    SOP Standard Operating Procedure


    NA Not Applicable
    Sr. Serial
    No. Number
    CFU Colony Orming Unit

    8.0 REFERENCE :

    ICHQ7

    9.0 SOP DISTRIBUTION:

    Name of Department Department Code


    Quality Assurance QA
    Quality control QC
    Production PD

    10.0 REVISION AND HISTORY:

    REV. NO. REASON FOR REVISION


    00 New SOP

    SOP/QA/001-F01.00 The document is covered under IPR of Sun Moon Pharmaceuticals Pvt. Ltd. and should not be reproduced without authorization.

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