Your ISO 13485 Certificate Will Not Protect You in a KGMP Inspection.
ISO 13485 compliance does not equal KGMP compliance.
Many foreign manufacturers assume that their ISO 13485-certified Quality Management System is sufficient for a Korean GMP (KGMP) inspection. This is a dangerous and expensive misconception. KGMP, governed by the Korean Medical Device Act and enforced by the MFDS, imposes site-specific requirements for procedures, records, and forms that have no direct equivalent in ISO 13485. A single Major Non-conformity finding — whether for a missing SOP, a non-compliant record format, or an undocumented process — is sufficient grounds for the inspector to issue a corrective action demand, suspend the inspection, and delay your product registration by 6 to 12 months.
A line-by-line KGMP audit before the inspector arrives.
We review your existing quality documentation through the critical lens of a KGMP inspector. Our bilingual regulatory experts cross-reference your current SOPs, work instructions, and quality records against the full scope of KGMP requirements to identify every gap that poses a material inspection risk.
SOP & Work Instruction Coverage
Identifying which procedures required under KGMP are absent, incomplete, or insufficiently detailed in your current QMS documentation.
Form & Record Compliance
Evaluating whether your quality records and forms meet the specific KGMP-mandated format and content requirements, including lot traceability, change control, and deviation records.
Process-Level Gap Mapping
Assessing site-specific KGMP requirements for complaint handling, CAPA, internal audit, management review, and supplier qualification that differ substantively from ISO 13485 expectations.
The KGMP Gap Analysis Report & Remediation Roadmap
You will receive a structured, inspection-ready report that maps your current QMS state against KGMP requirements and provides a clear, prioritized action plan to close every identified gap before your inspection date.
- Clause-by-clause KGMP compliance matrix with pass, gap, and critical gap designations for each requirement.
- Prioritized list of missing or non-compliant SOPs and forms, with recommended remediation actions for each.
- Risk-ranked findings that distinguish between Minor observations and Major Non-conformity risks, so your team focuses remediation effort where it matters most.
- Realistic timeline and resource estimate for completing all required documentation before your KGMP inspection.
Eliminate the risk of a Major Non-conformity before it happens.
A Major Non-conformity finding during a KGMP inspection does not merely delay your registration — it signals a systemic quality failure to the MFDS, creates a formal corrective action record, and forces a costly re-inspection cycle. By identifying and closing every critical gap upfront, you protect your inspection outcome, preserve your registration timeline, and demonstrate to the MFDS the quality posture of a prepared, credible manufacturer.
Speak with a KGMP Compliance Expert TodayFrequently Asked Questions
Common questions about KGMP gap analysis.