Korea · Foreign Site KGMP Audit
Complete KGMP Audit Defense for Foreign Manufacturing Facilities
Combining coordination across Korea’s 4 designated quality audit bodies (KTL, KTR, KTC, KCL) and regional MFDS offices with our proprietary MFDS review database, we compress preparation timelines to 1/5 and systematically prevent recurring deficiency cycles across 31-dossier desk audits and on-site inspections.
Domain Expertise
Deep regulatory authority across every medical device domain
SaMD · AI Digital Health
IEC 62304 · Software Lifecycle · MFDS AI/Big Data & DTx Guidance
Defended complex software validation and clean manufacturing lines during on-site audit for clean pass.
Active Devices · Robotics
IEC 60601-1 / 60601-1-2 (Ed. 4.1) · IEC 60601-2-XX Particular Standards
Essential Performance definition and worst-case test matrix optimization across accredited laboratories
Implants · Biomaterials
ISO 10993-1 to 23 Biocompatibility · ISO 11135 / 11137 Sterilization Validation
Biological endpoint matrix design and ISO 10993-18 chemical characterization / toxicological assessment
In Vitro Diagnostics (IVD)
Korea IVD Act & EU IVDR (2017/746) · CLSI EP Guidelines (EP05, EP06, EP12, EP17)
CLSI-compliant Limit of Detection (LoD), cross-reactivity, interference, and lot-to-lot reproducibility protocols
Proprietary Data & Precedent Validation
20+ Mandatory KGMP Dossier Cross-Checks & Inspection Analytics
100% Pre-Submission Verification of Foreign Facility Dossiers & Audit Evidence
Engineered 4-Stage Workflow
A 4-Stage Pipeline from Track Lock to KGMP Certificate Issuance
Locked Audit Track (Desktop/On-Site) & Document List
Incomplete baseline data or misclassified regulatory pathways are the primary drivers of multi-month submission delays. Gate 01 locks the device scope, predicate/standard mapping, and full document inventory before authoring begins.
Verification Baseline
Device description, intended use, existing test reports, and QMS document index
Gate Sign-Off Output
Confirmed classification matrix and locked submission master inventory
Agentic Automation & Platform Integration
Unified Cross-Border Facility Dossier & Audit CAPA Automation
Automated KGMP Dossier Indexing & Version Lock
Structure dozens of plant SOPs, SMFs, and validation files directly into the statutory MFDS table of contents.
@Audit Management— Run "Automated KGMP Dossier Indexing & Version Lock" across our Foreign Site KGMP Audit records and call out the highest-priority compliance findings first.
I'll inspect the linked quality and dossier records against target regulatory standards, then report actionable findings with verified outputs.
Thought for 4.2s · Explored Audit Management records & 14 regulatory clauses
Structure dozens of plant SOPs, SMFs, and validation files directly into the statutory MFDS table of contents. Audit planning with finding and CAPA linkage
Real-Time Cross-Border CAPA Collaboration
Coordinate plant engineers and Korean RA specialists on a single tracker to close inspection observations within statutory windows.
@Document Control— Run "Real-Time Cross-Border CAPA Collaboration" across our Foreign Site KGMP Audit records and call out the highest-priority compliance findings first.
I'll inspect the linked quality and dossier records against target regulatory standards, then report actionable findings with verified outputs.
Thought for 4.3s · Explored Document Control records & 14 regulatory clauses
Track KGMP expiration dates and facility relocation triggers in RIM to prevent import customs holds. Full document lifecycle with version control
Service Specification
Service Scope & Final Deliverables
Scope
Comprehensive evaluation and alignment of foreign production facilities, validation files, and QMS against statutory MFDS KGMP standards.
- Site master file, facility layout, cleanroom HVAC, and water system qualification review
- Process validation, sterilization validation, and software lifecycle audit
- Clause-by-clause alignment with mandatory KGMP quality management standards
- Batch production records, release testing, supplier qualification, and CAPA logs
- Defense coordination during MFDS on-site audit or desktop evaluation
Deliverables
Submission-ready regulatory dossiers and statutory certification confirming compliant manufacturing status in Korea.
- KGMP Clause-by-Clause Gap Matrix and Pre-Audit Remediation Plan
- MFDS Site Dossier Package (Facility layouts, utility qualifications, validation files)
- Mock Audit Findings Report and Inspector Q&A Defense Playbook
- Official KGMP Certification Application and Filing Receipts
- MFDS-Issued KGMP Certificate of Good Manufacturing Practice
| Category | Item / Milestone | Specification & Deliverable |
|---|---|---|
| Scope | Scope 1 | Site master file, facility layout, cleanroom HVAC, and water system qualification review |
| Scope | Scope 2 | Process validation, sterilization validation, and software lifecycle audit |
| Scope | Scope 3 | Clause-by-clause alignment with mandatory KGMP quality management standards |
| Scope | Scope 4 | Batch production records, release testing, supplier qualification, and CAPA logs |
| Scope | Scope 5 | Defense coordination during MFDS on-site audit or desktop evaluation |
| Workflow | Stage 1: Site QMS Intake & KGMP Gap Audit | Audit quality manual, manufacturing procedures, and batch records directly against statutory KGMP clauses. |
| Workflow | Stage 2: Korean Submission Dossier Compilation | Assemble facility qualifications, validation master files, and translated controlled procedures for MFDS review. |
| Workflow | Stage 3: Mock Inspection & Team Readiness Drills | Conduct on-site or virtual simulated audit challenging staff on inspector questions and records retrieval. |
| Workflow | Stage 4: MFDS Application, Audit Escort & Certificate Issuance | Submit formal filing, provide real-time defense during inspection, resolve deficiencies, and secure the certificate. |
| Deliverables | Deliverable 1 | KGMP Clause-by-Clause Gap Matrix and Pre-Audit Remediation Plan |
| Deliverables | Deliverable 2 | MFDS Site Dossier Package (Facility layouts, utility qualifications, validation files) |
| Deliverables | Deliverable 3 | Mock Audit Findings Report and Inspector Q&A Defense Playbook |
| Deliverables | Deliverable 4 | Official KGMP Certification Application and Filing Receipts |
| Deliverables | Deliverable 5 | MFDS-Issued KGMP Certificate of Good Manufacturing Practice |
Frequently Asked Questions
Ready to Secure Your Foreign Facility KGMP Certificate on the First Pass?
Backed by our proprietary MFDS review database, we defend 31-dossier desk audits and overseas on-site inspections with first-cycle audit precision.