MFDS On-Site GMP Inspection
Inspection coverage
MFDS on-site inspections cover:
- Document review — quality manual, procedures, records
- Facility tour — production areas, cleanrooms, storage, environmental monitoring
- Process observation — manufacturing processes, in-process controls
- Equipment verification — calibration records, maintenance logs
- Personnel interviews — key QMS personnel (QA Manager, production manager)
- Record review — batch records, CAPA records, complaint records, internal audit reports
Duration
Typically 1–3 days depending on facility size and product complexity.
Nonconformities
If nonconformities are identified:
- Manufacturer provides a CAPA plan within a specified timeframe
- Implements corrective actions
- Submits evidence of closure to MFDS
- Minor nonconformities: resolved without re-inspection
- Major nonconformities: may require a follow-up inspection