FACILITIES

Production Facility/QC

Our plants are operated to produce the best quality products with our GMP-certified facilities based on ISO13485:2016, the global standards.

Quality Control

Gencurix maintains a constant high level of product quality with rigorous and systematic quality policy based on the latest global regulations.

Establish a foundation for quality control

  • Establish internal product standards
  • Set-up quality policy and goals

Take a action

  • Corrective/preventive action activities (Immediate improvement or correction of nonconformities, Establishment of measures to prevent recurrence through preventive action)
  • Reflect and apply internal standard sheet 

Practice and monitoring

  • Internal audit (Review for effective quality systems)
  • IRegulatory requirements monitoring
  • IChange management/quality inspection
  • INonconforming product management

Assessment and Review

  • External regulatory agency audit (Verify the adequacy of the quality system)
  • Management review
  • Validation of equipment/production process

Certificates

  • Korea Good Manufacturing Practice (KGMP)
  • ISO 13485:2016(TUV SUD)
  • ISO 9001:2015