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    Checklist For CTD Pre Submission Screening

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    Ayub Naveed
    This document is a checklist for screening drug applications submitted to a regulatory agency before formal review. It lists required documents and information for the application, including submission forms, fees, manufacturing approvals, quality documents, and stability data. For imported products, it additionally requires certificates of pharmaceutical product and good manufacturing practices from the exporting country. The checklist must be completed to confirm that all necessary information is included before the application will be accepted for detailed evaluation.

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    Checklist For CTD Pre Submission Screening

    Uploaded by

    Ayub Naveed
    160 views2 pages
    This document is a checklist for screening drug applications submitted to a regulatory agency before formal review. It lists required documents and information for the application, including submission forms, fees, manufacturing approvals, quality documents, and stability data. For imported products, it additionally requires certificates of pharmaceutical product and good manufacturing practices from the exporting country. The checklist must be completed to confirm that all necessary information is included before the application will be accepted for detailed evaluation.

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    Checklist-for-CTD-Pre-submission-screening

    Original Title

    5.-Checklist-for-CTD-Pre-submission-screening

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    This document is a checklist for screening drug applications submitted to a regulatory agency before formal review. It lists required documents and information for the application, including submission forms, fees, manufacturing approvals, quality documents, and stability data. For imported products, it additionally requires certificates of pharmaceutical product and good manufacturing practices from the exporting country. The checklist must be completed to confirm that all necessary information is included before the application will be accepted for detailed evaluation.

    Copyright:

    © All Rights Reserved
    Download as DOCX, PDF, TXT or read online from Scribd
    Download as docx, pdf, or txt
    160 views2 pages

    Checklist For CTD Pre Submission Screening

    Uploaded by

    Ayub Naveed
    This document is a checklist for screening drug applications submitted to a regulatory agency before formal review. It lists required documents and information for the application, including submission forms, fees, manufacturing approvals, quality documents, and stability data. For imported products, it additionally requires certificates of pharmaceutical product and good manufacturing practices from the exporting country. The checklist must be completed to confirm that all necessary information is included before the application will be accepted for detailed evaluation.

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    Checklist for CTD Pre-Submission Screening Doc PE&R/LST/AR/001 Ver 01

    CTD PRE-SUBMISSION SCREENING CHECKLIST


    Note: Application shall be received for detailed evaluation if all the below mentioned documents
    are submitted.
    1. Form 5-F: Yes No

    2. Requisite fee: Yes No

    3. Valid DML / DSL: Yes No

    4. Evidence of GMP compliance of relevant section: Yes No

    5. Evidence of approval status in RRA: Yes No

    6. QOS (Quality Overall Summary) as per WHO QOS-PD Template: Yes No

    For Module-3, in Drug Substance Part:


    3.2.S.2.1: Manufacturer(s) site address Yes No
    3.2.S.4.4: Certificate of Analysis (COA) of both drug substance(s) manufacturer Yes No
    and drug product manufacturer:
    3.2.S.7: Stability data of 3 batches at accelerated and real time conditions: Yes No
    For Module-3, in Drug Product Part:
    3.2.P.2.2.1: Product development, description of dosage form, Pharmaceutical Yes No
    Equivalence through Comparative Dissolution Profile (where applicable)
    [Explanation: Pharmaceutical Equivalence is mandatory for each dosage
    form/product while Comparative Dissolution Profile is required as
    applicable]
    3.2.P.3.5: Process validation: Yes No
    3.2.P.5.1: Specifications of drug product: Yes No
    3.2.P.5.3: Validation / verification of analytical procedures summary / reports: Yes No
    3.2.P.8.3: Stability data: Yes No
    FOR IMPORTED PRODUCTS (Following additional documents)
    Original, legalized and valid CoPP / Free sale and GMP certificate Yes No
    Sole agency agreement / authorization letter Yes No
    Remarks (if any):
    _________________________________________________________________________________
    _________________________________________________________________________________

    Received Returned back to applicant for completion

    Page 1 of 2
    Checklist for CTD Pre-Submission Screening Doc PE&R/LST/AR/001 Ver 01
    #

    Date Name & Signature

    Page 2 of 2

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