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    Content Remarks: Annexures To Module 3

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    Harischandran
    The document provides a status update on the modules required for a drug application. Module 1 is mostly complete except for the BTIF and COPP of LE documents. Module 2 is partially complete with the CTD Summary and some annexures finished, but the Quality Overall Summary and analytical procedures are pending. Module 3 requires the execution production documents to be reviewed before scanning, and the analytical validation report, process validation documents, and stability protocol and report are pending. Module 4 is complete, and Module 5 requires the BE study report. Overall, several documents still need to be finished or reviewed before the application is fully complete.

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    Content Remarks: Annexures To Module 3

    Uploaded by

    Harischandran
    12 views1 page
    The document provides a status update on the modules required for a drug application. Module 1 is mostly complete except for the BTIF and COPP of LE documents. Module 2 is partially complete with the CTD Summary and some annexures finished, but the Quality Overall Summary and analytical procedures are pending. Module 3 requires the execution production documents to be reviewed before scanning, and the analytical validation report, process validation documents, and stability protocol and report are pending. Module 4 is complete, and Module 5 requires the BE study report. Overall, several documents still need to be finished or reviewed before the application is fully complete.

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    dossier status

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    Dossier Status

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    The document provides a status update on the modules required for a drug application. Module 1 is mostly complete except for the BTIF and COPP of LE documents. Module 2 is partially complete with the CTD Summary and some annexures finished, but the Quality Overall Summary and analytical procedures are pending. Module 3 requires the execution production documents to be reviewed before scanning, and the analytical validation report, process validation documents, and stability protocol and report are pending. Module 4 is complete, and Module 5 requires the BE study report. Overall, several documents still need to be finished or reviewed before the application is fully complete.

    Copyright:

    © All Rights Reserved
    Download as DOCX, PDF, TXT or read online from Scribd
    Flag for inappropriate content
    Download as docx, pdf, or txt
    12 views1 page

    Content Remarks: Annexures To Module 3

    Uploaded by

    Harischandran
    The document provides a status update on the modules required for a drug application. Module 1 is mostly complete except for the BTIF and COPP of LE documents. Module 2 is partially complete with the CTD Summary and some annexures finished, but the Quality Overall Summary and analytical procedures are pending. Module 3 requires the execution production documents to be reviewed before scanning, and the analytical validation report, process validation documents, and stability protocol and report are pending. Module 4 is complete, and Module 5 requires the BE study report. Overall, several documents still need to be finished or reviewed before the application is fully complete.

    Copyright:

    © All Rights Reserved
    Download as DOCX, PDF, TXT or read online from Scribd
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    Download as docx, pdf, or txt
    of 1

    Content Remarks

    Module 1
    BTIF To be collected from Accutest
    Annexures (MGF. Lic. of FPP, API, LoA, GMP
    Completed
    certificates, Artworks etc.)
    COPP of LE To be applied
    SmPC Completed
    QIS Completed
    Module 2
    CTD Summary Completed
    Quality overall summary Pending
    Module 3
    Review to be completed before
    Executed Production Documents
    scanning
    Master Production Documents Completed
    Analytical Proc. & Val. Info Pending
    Annexures to Module 3
    TSE-BSE certificates of Excipients Completed
    Analytical method validation report Pending
    CoAs of FPP Completed
    CoA of API from FPP mfg. Completed
    SOP for Working Standard & Results SOP completed, Results pending
    Process Validation Protocol & Report Pending
    Product Development Report Pending
    List of production and QC equipment Completed
    FPP Specification & testing Procedure Completed
    STP of Primary packing Completed
    6 months report completed,
    Stability Protocol and report
    protocol pending
    API MF Completed

    Module 4
    Not applicable Completed
    Module 5
    BE Study report Pending

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