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    COSMETIC - Process For AdditionDeletion of Supplier or TPM

    Uploaded by

    Crystal Santiago
    The document outlines the steps for adding or deleting a supplier or third party manufacturer for cosmetic products. It involves securing documents from the new supplier, conducting a supplier quality audit, informing suppliers of requirements, signing agreements, updating lists, and applying for regulatory approval before production can begin.

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    © All Rights Reserved
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    COSMETIC - Process For AdditionDeletion of Supplier or TPM

    Uploaded by

    Crystal Santiago
    12 views3 pages
    The document outlines the steps for adding or deleting a supplier or third party manufacturer for cosmetic products. It involves securing documents from the new supplier, conducting a supplier quality audit, informing suppliers of requirements, signing agreements, updating lists, and applying for regulatory approval before production can begin.

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    COSMETIC_Process for AdditionDeletion of Supplier or TPM

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    The document outlines the steps for adding or deleting a supplier or third party manufacturer for cosmetic products. It involves securing documents from the new supplier, conducting a supplier quality audit, informing suppliers of requirements, signing agreements, updating lists, and applying for regulatory approval before production can begin.

    Copyright:

    © All Rights Reserved
    Download as DOCX, PDF, TXT or read online from Scribd
    Download as docx, pdf, or txt
    12 views3 pages

    COSMETIC - Process For AdditionDeletion of Supplier or TPM

    Uploaded by

    Crystal Santiago
    The document outlines the steps for adding or deleting a supplier or third party manufacturer for cosmetic products. It involves securing documents from the new supplier, conducting a supplier quality audit, informing suppliers of requirements, signing agreements, updating lists, and applying for regulatory approval before production can begin.

    Copyright:

    © All Rights Reserved
    Download as DOCX, PDF, TXT or read online from Scribd
    Download as docx, pdf, or txt
    of 3

    Steps to take for the ADDITION/DELETION OF SUPPLIER/TPM FOR COSMETIC PRODUCTS.

    For SCD:

    Process / Requirement Source / Responsible Team


    1. Inform RA/R&D/QA of the planned change (Addition or SCD
    Deletion) via email or Change Control, if applicable
    2. Secure availability of the following documents from the new SCD
    supplier /TPM:
     Copy of License to Operate (as Cosmetic Manufacturer)
     Copy of GMP Certification (as issued by PH FDA)

    3. Accomplish Supplier Quality Audit. Secure copy of the audit SCD / QA


    report for filing and future FDA inspection.
    4. Inform supplier that the following must be complied prior to SCD
    start of production of PC products:
     Amendment to their product listing under their LTO
    adding the PC products to be manufactured. Secure a
    copy once available.
     Amendment to the Client Listing, adding PC as one of
    their Trader/Client/Distributor under their LTO. Secure
    a Copy once available.
    5. Secure availability of notarized SUPPLIER-PC AGREEMENT SCD
    6. Add the Qualified Supplier to the Supplier Master List (update SCD
    the Supplier Master List)
    7. Wait for availability of NN before manufacture/production of SCD
    the product.
    Note: Evaluation to Approval/Denial takes 14 working days or
    more depending on product evaluation

    References: FDA Memorandum Circular 2015-011, E-Cosmetic Notification Manual,


    Steps to take for the ADDITION/DELETION OF SUPPLIER/TPM FOR COSMETIC PRODUCTS.

    For RA:

    Process / Requirement Source / Responsible Team


    1. File for Addition of Source, adding or deleting the supplier, as RA
    Amendment to the LTO. Amendment to the list of products
    manufactured by Toll Manufacturer.
    2. Apply for NN. RA
    References: FDA Memorandum Circular 2015-011, E-Cosmetic Notification Manual,
    Steps to take for the ADDITION/DELETION OF SUPPLIER/TPM FOR COSMETIC PRODUCTS.

    For R&D PD / PackDev:

    Process / Requirement Source / Responsible Team


    3. Prepare documents for NN.
    a) Full ingredient Listing (using INCI names and in PD
    decreasing order of composition in the formula),
    indicating the percentage of any restricted ingredient
    as per ACD
    b) Scanned Copy of Clear and Complete loose labels or Pack Dev
    artworks of all packaging sizes, including inner and
    outer cartons, if any.

    c) Technical Substantiation for claims: PD

    i. Technical studies and reports


    ii. Mechanism of actions for active ingredient with
    claims
    iii. COA and quantitative analysis and computations

    References: FDA Memorandum Circular 2015-011, E-Cosmetic Notification Manual,

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