Assessment of Compliance with Good Manufacturing Practices (CPOB) for Imported Drug Manufacturing Facilities.

  • MSME Information Details
    • Parameter: All
    • Authority: Minister/Head of Agency
    • Requirements
      1. Proof of payment of Non-Tax State Revenue (PNBP)
      2. Duration: -
      3. Standard and Assessment Requirements for Compliance with Pharmaceutical Manufacturing Facilities for Imported Drugs
      4. Duration: -
    • Obligations
      1. Submit pre-inspection documents if the evaluation result indicates a desktop inspection;
      2. Duration: -
      3. Submit an inspection request and completeness of pre-inspection documents if unable to submit documents for desktop inspection within 80 (eighty) days;
      4. Duration: -
      5. Submit an inspection request and completeness of pre-inspection documents if the evaluation result indicates the need for on-site inspection;
      6. Duration: -
      7. Continue the registration process for imported drugs if the assessment meets the GMP requirements.
      8. Duration: -
      9. Submit an inspection request and completeness of documents, if on-site inspection is required; or;
      10. Duration: -
      11. Continue the registration process for imported drugs, if the document evaluation meets the GMP requirements.
      12. Duration: -
      13. Submit a report on transportation and accommodation costs after the inspection is conducted;
      14. Duration: -
      15. Submit CAPA documents if there are findings during the inspection after the inspection decision is issued in the form of a CAPA request.
      16. Duration: -
      17. Submit CAPA corrections, a maximum of 2 (two) CAPA corrections.
      18. Duration: -
Sector: Drugs and Food.
Status: Available
Belongs to:
21012

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