R&D

Kolmar Korea continuously challenges to develop new technologies to become a world-first-class R&D manufacturing company.

Global Quality Framework

Kolmar Korea operates a Global Quality Framework to ensure consistent quality across every stage of product development from formulation and manufacturing to distribution.
Kolmar Korea’s Global Quality Framework is designed to deliver safe and reliable products at all manufacturing sites worldwide.

  • Quality Principles Safety, reliability, and consistency are established as the core principles of our quality management.

    • An integrated quality policy based on global standards
    • Management of quality accountability indicators (KPI) across all global sites in line with our Quality First philosophy
    • Application of Design by Quality, ensuring quality is built into products from the development stage
  • Global Standard Quality System We operate a standardized system that ensures consistent quality anywhere in the world.

    • Application of global standards for core processes and quality control through SOPs (Standard Operating Procedures)
    • Unified production and testing operations based on CGMP and ISO requirements, including harmonized test methods and inspection criteria
  • Risk Management Quality risks are proactively managed, and in the event of an issue, we communicate with our customers promptly and transparently.

    • Operation of a globally integrated risk management process
      Global escalation flow: Local QA → Global (GAO) QA → Headquarters
    • Systematic response to quality issues through root cause analysis, improvement actions, and effectiveness verification based on impact, severity, and scope
    • Transparent, customer-centric communication
  • Continuous Quality Capability Enhancement Through ongoing investment, education, and audit systems,
    we continuously strengthen our global quality competitiveness.

    • Establishment of a compliance framework aligned with global regulations,
      including ISO, FDA, Health Canada, and NMPA
    • Enhancement of supply chain quality through a global supplier quality audit system
    • Operation of global quality training programs across all sites,
      covering QA, QC, R&D, and manufacturing
Quality Control System

Kolmar Korea’s global No.1 technology results in quality competitiveness.
Kolmar Korea establishes global standards based on its 6-step QC system that conforms to the strict validation system used by various home/overseas institutions and brand companies.

6-step QC system

  1. ① Raw Materials & Packaging Materials Testing
    Through physical and chemical Testing the quality of raw materials and packaging materials is verified in accordance with established Specifications and their conformity or nonconformity is determined.
  2. ② Raw Material Weighing Process Inspection
    Through physical and chemical Testing the quality of raw materials and packaging materials is verified in accordance with established Specifications and their conformity or nonconformity is determined.
  3. ③ Manufacturing Process Inspection
    Key process parameters such as temperature and time are monitored to confirm compliance with established standards and product quality is inspected immediately after manufacturing.
  4. ④ Bulk Testing
    Testing is conducted to verify that semi-finished products meet quality specifications and decisions are made on whether to proceed to the next process.
  5. ⑤ Filling & Packaging Process Inspection
    Appearance, weight, and sealing conditions are inspected, and compatibility between the product and packaging materials is verified.
  6. ⑥ Finished Product Testing
    Through final testing, the finished product’s compliance with specifications is confirmed, and release eligibility is determined.
  7. RM/PM Test
  8. In-Process Inspection
  9. Bulk test
  10. In-Process Inspection
  11. Finished Product Tests