SOP & Work Instruction Coverage
Procedures missing, incomplete, or too thin under KGMP.
KGMP Gap Analysis
Your ISO 13485 Certificate Will Not Protect You in a KGMP Inspection.
ISO 13485 compliance does not equal KGMP compliance.
Form & Record Compliance
Records and forms against KGMP format — lot trace, change control, deviations.
Process-Level Gap Mapping
Site-specific gaps in complaints, CAPA, internal audit, and supplier qualification.
Service specification
Korea KGMP Gap Analysis
Inspection-ready report mapping your current QMS state against KGMP, with a prioritized action plan to close every gap before inspection day.
Request assessmentISO 13485 doesn't cover the site-specific procedures, records, and forms KGMP demands. A single Major Non-conformity can delay registration by 6–12 months.
Inspection-ready report mapping your current QMS state against KGMP, with a prioritized action plan to close every gap before inspection day.
Required procedures missing; Format compliance check; Site-specific gap mapping; Major / Minor classification
Clause-by-clause status; Prioritized authoring queue; Pre-inspection schedule; Effort and budget estimate
The analysis itself typically takes 3 to 5 weeks depending on the size and complexity of your QMS documentation. Remediation timelines vary by the number and severity of gaps found, but our report includes a realistic implementation schedule to guide your team's preparation effort before the inspection.
KGMP success across modalities.
Class III Orthopedic Implant
Closed 23 critical SOP gaps in 6 weeks. Inspection closed without major non-conformities.
Contract Manufacturer
Authored 47 KGMP-aligned SOPs in 4 months. Full certification on first audit cycle.
Multi-Site Global Brand
Harmonized 3 manufacturing sites under a single KGMP framework.
Frequently Asked Questions
Common questions about KGMP gap analysis.