Quality management(GMP)
We build a quality system to your company's situation accord to Manufacturing Quality Management standards.
CONSULTING
- Consulting subject
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- Manufactory that medical devices under Article 8 and 31 of the Enforcement Regulations of the Medical Device Act and Korea Good Manufacturing and Quality Control Practices for Medical Devices.
- Detail of consulting contents
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- KGMP (Initial, Change, Regular, Addition) and Clinical GMP under Article 6 of the Medical Devices Act and Article 8 of the Enforcement Regulations of the Medical Device Act
- Manufactory organization consulting (Organization system, selection of quality managers etc.) under Article 10 and 11 of the Enforcement Regulations of the Medical Device Act etc.
- Foreign Manufacturer GMP (Initial, Modification, Regular, Addition) under Article 33 of the Enforcement Regulations of the Medical Device Act
- Procedure
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- Review & Guide of Documentation provided by manufacturer.
- Provide KGMP Application Documents Requirements
- Review Received Application Documents
- Review quality system documents of Manufacturer
- Assist and coordinate KGMP Audit Agency
- Arranging an Audit schedule of MFDS Designated KGMP Audit Agency
- Supplement of Submission Documentation
- Feedback on the supplements caused by the KGMP Audit.
- Act as a liaison between the MFDS Designated KGMP Audit Agency and the Manufacturer(importer).
