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KGMP Audit Support
Prepare the manufacturing-site quality system from the Korean KGMP audit perspective.
When a review helps
Check quality documentation and readiness
Address audit questions and follow-up actions
When is this service useful?
KGMP is not simply the submission of a certificate. It assesses quality-system conformity by manufacturing site and product group. ISO 13485 evidence is important, but the Korean application scope and supporting records still require separate review.
Key areas of review
Scope confirmation
Identify manufacturing sites, product groups and the likely assessment type.
Gap review
Assess the quality manual, procedures and key records for readiness.
Audit support
Support preparation for document or on-site questions and supplementary evidence.
Prepare for your review
- ISO 13485 certificate
- Quality manual and procedures
- Manufacturing process and outsourced-process records
- Internal audit, CAPA and complaint records
How We Work
Set the assessment scope
Confirm the manufacturing sites and product groups.
Review documentation
Assess QMS documents and representative records.
Prepare application and audit
Organize the application, evidence and interview responses.
Close and maintain
Manage findings, supplementary evidence and recurring-assessment timing.
Review the site and quality documents together
Clarify product/site scope, documentation readiness and response owners to prioritize audit preparation.
The specific scope and deliverables are agreed after product and evidence review.
Frequently Asked Questions
What should we prepare for an initial discussion?
Product information, intended use, manufacturing details, approvals and available testing evidence.
When can timing be estimated?
After likely classification and material evidence gaps have been reviewed.
MFDS medical-device regulations · MFDS medical-device approval process · Content baseline · Check current requirements for the specific product
CONSULTATION
Start a consultationClarify the Korean regulatory pathway for your product.
Attach what you have and we will reply by email after reviewing it. You do not need a complete set of documents.