Certificate of Compliance with Good Manufacturing Practices for Cosmetics - Category B

UMKU Detail

Parameter: All

Authority: Minister/Head of Agency

Requirements:

  1. Evidence of payment of Non-Tax State Revenue (PNBP)

    2. Duration: -

  2. Approval letter for the use of shared facilities that is still valid in the dosage form according to the application for production facilities that use shared facilities with drugs or traditional medicines (specifically for pharmaceutical or traditional medicine industries)

    3. Duration: -

  3. Specifically for Technical Changes: Documentation of the implementation of the CPKB quality system adjusted to the proposed technical changes

    4. Duration: -

  4. Documentation of the implementation of the CPKB quality system, including:
    • Sanitation and hygiene
    • Documentation in accordance with the regulations of the Food and Drug Authority regarding CPKB

    Duration: -

  5. Approval of the Layout of Cosmetic Industry Buildings

    6. Jangka Waktu: -

  6. Specifically for Administrative Changes:
    • Legal documents stating a change in the company's name/legal entity (notary deed)
    • Documents from the local government stating a change in address without a change in location
    • Legal documents stating a change in the name of the company's leader/director (notary deed)
    • Legal documents stating a change in the name of the technical responsible person and documents of the new technical responsible person's work contract with the company's leader/director

    Duration: -

  7. Technical data form for Compliance Certificate for Good Cosmetic Manufacturing Practices Group B

    8. Jangka Waktu: -

Obligations:

  1. Ensure the consistency of CPKB implementation in accordance with regulations

    2. Duration: -

Sector: Medicine and Food
Status: Available
Belongs to:
20232

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