KGMP Certification
ISO 13485 Won't Pass KGMP. Korea Requires Korea-Specific Preparation.
When KGMP Certification Is the Right Fit.
Three scenarios where foreign manufacturers face an MFDS inspection ISO-grade prep can't pass.
First-Time KGMP for an ISO 13485 Manufacturer
ISO 13485-certified, first KGMP — Korea-specific gap closure on SOPs, records, and inspection methodology.
Re-Inspection After a Prior Failed KGMP
Prior inspection produced major non-conformances — corrective actions, QMS rebuild, re-inspection prep.
Foreign Manufacturer KGMP Site Inspection
Overseas QMS site, MFDS on-location inspection — Korean materials, interpretation, on-site support end-to-end.
Every Deliverable Required to Pass a KGMP Inspection.
Three coordinated services that prepare, defend, and recover the KGMP certificate.
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Line-by-Line KGMP Gap Report
QMS audited against each KGMP clause, with a written gap list classified by inspection risk.
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Korean-Language SOP Revision
SOPs drafted or revised in Korean to KGMP conventions — the most common gap in ISO-certified foreign QMS.
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Record Format Correction
Production, quality, and DHF records revised to the Korean-format conventions MFDS inspectors evaluate.
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Process Validation Documentation
IQ/OQ/PQ documentation authored or supplemented to MFDS-expected depth for your device type.
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Mock Audit Against MFDS Methodology
Mock audit run on the same KGMP criteria MFDS applies — inspection-day findings surfaced before the inspector arrives.
KGMP Certifications Delivered for Domestic and Overseas Manufacturing Sites.
First-Cycle KGMP Certification for an ISO-Certified European Manufacturer
Re-Inspection Recovery for a Manufacturer With a Prior Failed Inspection
Frequently Asked Questions
Common questions answered.
Your KGMP Certificate — Issued by MFDS.
We know what MFDS inspectors examine and what a defensible KGMP QMS looks like on inspection day.
Speak with a KGMP Certification Expert Today