Approval for the Shared Use of Traditional Herbal Medicine Production and/or Testing Facilities with Quasi-Drugs, Cosmetics, and Processed Foods.

UMKU PB Details

Parameter: All

Authority: Minister/Head of the Agency

Requirements

  1. Proof of payment of PNBP

    2. Duration: -

  2. CPOTB certificate or Gradual CPOTB Compliance Certificate at least Stage 2 for jointly used facilities (Specific to Production Facilities for UKOT/UMOT, Testing Facilities for UKOT/UMOT)

    3. Duration: -

  3. CPOTB certificate for jointly used facilities (Specific to IOT Production Facilities)

    4. Duration: -

  4. Request Letter

    5. Duration: -

  5. Formulas for products to be produced in shared facilities

    6. Duration: -

  6. Statement of Responsibility stating that: 1) there is still excess capacity to produce non-traditional drugs (Specific to Production Facilities) 2) active raw materials and excipients used must have pharmaceutical grade / food grade quality (at least) 3) production of non-traditional drugs does not affect the quality testing of products and does not affect the storage of traditional drugs (Specific to Production Facilities) 4) having excess capacity to test non-traditional drugs

    7. Duration: -

  7. Data matrix of jointly used production equipment, including: the name and ID of equipment for each stage of the process, document number for cleaning procedures, and product markers (if any). (Specific to Production Facilities)

    8. Duration: -

  8. Production planning for traditional and non-traditional drugs to prevent the possibility of cross-contamination (Specific to Production Facilities)

    9. Duration: -

  9. Equipment and room cleaning procedures for joint production. (Specific to Production Facilities)

    10. Duration: -

  10. Equipment cleaning validation protocol including the analytical method used in the cleaning validation. (Specific to Production Facilities)

    11. Duration: -

  11. Procedures and layout for storing raw materials and packaging materials, as well as finished products for traditional and non-traditional products to be produced jointly. (Specific to Production Facilities)

    12. Duration: -

  12. Testing plans for traditional and non-traditional drugs to prevent cross-contamination (Specific to Testing Facilities)

    13. Duration: -

  13. Validation protocols and reports for jointly used equipment cleaning, as well as validation protocols and reports for the analytical method used (Specific to extensions)

    14. Duration: -

Responsibilities

  1. Ensure that Traditional Medicines are not contaminated with Non-Traditional Medicines.

    2. Duration: -

Sector: Drugs and Food.
Status: Available
Belongs to:
21022

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