Korean Good Manufacturing Practice
Korean Good Manufacturing Practice (KGMP) is South Korea’s GMP standard for medicines, set under the Pharmaceutical Affairs Act and the Ministry of Food and Drug Safety’s implementing rules on the safety of pharmaceuticals. KGMP conformity is a condition of manufacturing and import approval. MFDS joined the Pharmaceutical Inspection Co-operation Scheme (PIC/S) in July 2014 and became an ICH regulatory member in 2016, keeping KGMP aligned with the PIC/S GMP Guide and the ICH quality guidelines.
What this does not cover
stated in the document's own scope- Sets manufacturing GMP for medicines; product approval and registration follow MFDS’s separate pathways.
- Applies to sites supplying the Korean market, including foreign manufacturers of imported products, which MFDS may assess directly.
- The primary instruments are published in Korean; English summaries exist but the Korean text governs.
Always verify against the current published text before relying on it for a submission or inspection.
Overview
Korean Good Manufacturing Practice (KGMP) is South Korea’s GMP standard for medicines, administered by the Ministry of Food and Drug Safety (MFDS). It sets the manufacturing requirements a site must meet — pharmaceutical quality system, personnel, premises and equipment, documentation, production, quality control, and validation — as a condition of manufacturing and import approval. KGMP is maintained in alignment with the PIC/S Guide to Good Manufacturing Practice, and MFDS assesses conformity through documentary review and on-site inspection before and during a product’s commercial life.
Scope & applicability
Manufacturers and importers supplying the Korean market. KGMP sets the manufacturing standard; product approval and registration follow MFDS’s separate pathways.
Legal basis & how it acquires force
KGMP takes its authority from the Pharmaceutical Affairs Act, South Korea’s primary medicines statute, and the Ministry’s implementing rules on the safety of pharmaceuticals and related notifications. These are binding instruments for the Korean market, so KGMP compliance is a legal condition of the manufacturing or import licence rather than advisory guidance. MFDS is the competent authority that issues the rules, conducts the GMP assessments, and grants the approvals to which KGMP conformity is tied.
Document structure
| Part | Covers |
|---|---|
| Pharmaceutical quality system | Quality management, quality risk management, and product quality review |
| Personnel and premises | Organisation, training, hygiene, and facility and equipment requirements |
| Documentation | The documentation system, master and batch records, and data controls |
| Production and quality control | Manufacturing operations, in-process control, and the quality-control laboratory |
| Qualification and validation | Qualification of facilities and equipment and process, cleaning, and analytical validation |
Key requirements
- Demonstrate KGMP conformity as a condition of manufacturing or import approval.
- Operate a pharmaceutical quality system aligned with the PIC/S GMP Guide.
- Maintain the qualification, validation, and documentation the standard requires.
Implementation tips
- Read KGMP alongside the PIC/S GMP Guide and the ICH Q-series, which MFDS applies as a member of both regimes.
Revision notes
MFDS joined PIC/S in July 2014 and became an ICH regulatory member in 2016, converging KGMP with the international reference.
Where this control fails
live FDA enforcementLive FDA recalls SPEQ maps to this standard’s topics — a SPEQ interpretation, not an FDA classification.
International alignment
MFDS joined the Pharmaceutical Inspection Co-operation Scheme (PIC/S) in July 2014 and became an ICH regulatory member in 2016, later joining the ICH Management Committee. Those memberships are the reason KGMP tracks the PIC/S GMP Guide — which itself mirrors EU GMP — and the ICH quality guidelines (Q7 onward). The convergence keeps Korean requirements comparable with the international reference, while the binding obligation remains KGMP as enforced by MFDS under Korean law.
KGMP: frequently asked questions
Quick answers to common questions about KGMP.
What is KGMP?
KGMP is Korean Good Manufacturing Practice, the GMP standard administered by South Korea’s Ministry of Food and Drug Safety (MFDS) under the Pharmaceutical Affairs Act. Conformity is a condition of manufacturing and import approval and is maintained in alignment with the PIC/S GMP Guide.
Is Korea a member of PIC/S and ICH?
Yes to both. MFDS joined PIC/S in July 2014 and became an ICH regulatory member in 2016, which is why KGMP is harmonised with the PIC/S GMP Guide and the ICH quality guidelines.
Does KGMP apply to foreign manufacturers?
Yes. A foreign site making a product imported into Korea must meet KGMP, and MFDS may assess that conformity through documentary review or on-site inspection.
This standard in practice
Recall domain is a SPEQ mapping of this standard’s topics, not an FDA classification.