Korean Cosmetics OEM 5-Minute GMP Audit Checklist — Send Before You Quote
May 8, 2026
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TL;DR
Before moving from a Korean OEM's first meeting to quote and sample stages, sending 22 items in five minutes filters out 80% of paper-only operations, double-issued certificates, and weak QC.
The list lives in four categories:
- CERT (certifications) — 5 items
- FACILITY (facility) — 6 items
- QC (quality control) — 7 items
- COMMUNICATION — 4 items
Each item is a single email request, and the response itself is a signal of how the OEM operates.
CERT — Certifications (5 items)
| # | Item | Ask for | Pass criteria |
|---|---|---|---|
| 1 | GMP certificate PDF | "Please send the ISO 22716 or MFDS CGMP certificate" | Cert number, issue and expiry dates clear; verifiable Certification Body |
| 2 | Cert category match | "Confirm sun care OEM is in scope" | Certificate's product category matches your spec |
| 3 | FDA Facility ID (if applicable) | "Do you have an FDA registered facility ID?" | Required for US market intent (MoCRA) |
| 4 | EU CPNP RP (if applicable) | "Have you handled EU RP delegation before?" | Required for EU market intent |
| 5 | Cert renewal cadence | "Last audit date and next audit window" | ISO 22716 every 3 years, MFDS every 4 |
FACILITY — Facility (6 items)
| # | Item | Ask for | Pass criteria |
|---|---|---|---|
| 6 | 5+ facility photos | "Exterior, line interior, and QC lab photos" | Watermark/metadata verifiable, EXIF ≤ 6 months |
| 7 | Line count | "Number of production lines and daily capacity (kg)" | Self-reported figure matches MFDS registration |
| 8 | Utilization rate | "Current utilization % and next available slot" | 95%+ signals delayed responses |
| 9 | Cleanroom class | "ISO 14644 class and area" | Class 8 or better is the cosmetics standard |
| 10 | In-house R&D | "Number of in-house chemists, equipment list" | Real ODM verification |
| 11 | Audit-friendly | "When can we visit, in what language?" | Refusal is a red flag |
QC — Quality Control (7 items)
| # | Item | Ask for | Pass criteria |
|---|---|---|---|
| 12 | QC SOP page count | "Send the table of contents of the QC SOP" | <50 pages = warning, 80–150 typical |
| 13 | Microbial testing | "In-house or outsourced lab name" | Outsourced means longer lead time |
| 14 | Stability data | "Sample 3/6/12-month stability dataset" | Standardized format |
| 15 | Allergen testing | "24 EU fragrance allergen test method" | Required for EU/US export |
| 16 | Batch traceability | "Lot number → raw-material lot trace" | Core of cosmetics GMP |
| 17 | Reject rate | "Last 3-month average reject rate" | ≤0.5% recommended |
| 18 | External lab cert | "Outsourced lab's ISO 17025 status" | Test-data credibility |
COMMUNICATION (4 items)
| # | Item | Ask for | Pass criteria |
|---|---|---|---|
| 19 | Complaint SOP | "Share 1–2 anonymized recent complaint cases" | SOP-driven response, <5 days |
| 20 | Average response time | (Measure their own email response) | Business-day 24–48h ideal |
| 21 | Multilingual support | "Does the PM speak English/Japanese?" | Required for global launches |
| 22 | Standard NDA template | "Send your standard NDA PDF" | If it takes >1–2 days, immaturity signal |
How to Use
- Email the 22 items to the OEM — split across 4 emails by category, not all at once.
- Score response time + completeness on four axes:
- Answers ≥80%, response <48h → Trustworthy OEM. Move to quoting.
- Answers 50–80%, response 48–96h → Ask for context, then decide.
- Answers <50%, response >96h → Skip.
- If the OEM refuses to respond at all, treat as a paper company.
PDF Download
A downloadable PDF with the full 22 items plus a scoring sheet — coming in a follow-up insight.