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Quality Assurance

Comply with global GMP guildelines through
an independent quality assurance system.

Handong's quality organization
is operated separately from the production organization,
and the quality assurance department is responsible
for ensuring that all processes meet global GMP guidelines.
  • Planning

    - 위험평가(RA)

    - 영향평가(IA)

    - Analyze support resources

  • Operation

    - Quality documentation

    - qualification & validation

    - training

    - process control

  • Monitoring

    - Self-audit

    - Identify-trend

    - Deviations & Change control

  • Evaluation

    - GMP committee

    - Trend-analysis

    - Product quality

  • Resolution

    - Conduct CAPA

    - revise SOPs

  • Quality System
    Responsible for ensuring that all processes meet global GMP guidelines and requirements.
    Handong's quality department ensures that all processes are maintained and managed through the quality system to produce superior quality veterinary drugs.
  • Documentation System
    Digital document management system
    Handong operates a document management system that interfaces manufacturing instructions and records with ERP for controlled creation, management, and storage of GMP documents.
Handong's quality system manages and supervises that all equipment
and systems are maintained in accordance with global GMP guidelines
for the production of excellent quality animal products.

In addition, the Quality Assurance Department reviews and approves all specifications, standard operating procedures (SOPs), manufacturing instructions and records, as well as investigates and reviews all matters related to manufacturing and quality. Through the document management system, we manage KVGMP documents from creation to approval and storage, and strive for more effective quality system operation through regular self-inspections.

Handong's Quality Assurance Department strives for perfect quality through various programs such as corrective and preventive action activities (CAPA), quality risk assessment (RA), and process management through self-inspection. Through the activities of the Quality Assurance Department, Handong operates the global GMP standards and fully complies with the global GMP regulations.