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