Quality

TOP Business Quality Control

Quality Control System

We have established a quality management system compliant with the international standard ISO 22716 (GMP), implementing thorough quality checks from raw material acceptance through manufacturing and shipping. This ensures a stable supply of consistently high-quality products.

In our manufacturing environment, we maintain Class 100,000 cleanroom conditions, monitor and analyze airborne particles, and inspect for hair, fibers, and dust. This eliminates contamination risks even at microscopic levels, ensuring a consistently clean environment.

Through such advanced quality and environmental management, we are able to meet strict domestic and international standards. We have established a highly reliable manufacturing system that can respond to diverse global needs.

We also hold regular meetings to thoroughly share information and make continuous efforts to improve quality.

  • Certifications of
    International Standards
    Acquisition of ISO22716 Certification
    Certifications of International Standards
  • Global Requirements
    At domestic and overseas
    actories Acquisition
    of Halal Certification
    Global Requirements
  • Traceability
    Thorough Lot Management
    Video Recording by Camera
    Traceability

Thorough Quality Control at Each Process

In addition to strict quality control at all stages, we have established a high-level quality assurance system through the operation of the “Quality Gate System,” which manages the approval of raw materials and intermediates, as well as the shipment of finished products.。

PHASEProduct Design

  • Container Testing
  • Transportation Testing
Container Testing

The compatibility between container materials and contents (bulk) is tested to confirm product safety and evaluate whether quality can be maintained.

Transportation Testing

We also test products to withstand vibrations and shocks during transportation, ensuring that quality is maintained throughout the distribution process.

  • X-ray
  • Push-Pull Gauge
  • Microscope
  • FT-IR (Fourier Transform Infrared Spectroscopy)
Product Design

PHASERaw Material Acceptance

  • Incoming Inspection
Incoming Inspection

Inspect incoming raw materials and supplies to ensure they meet specified quality standards, and register the results in the system.
Packaging materials are checked by barcode scanning at two stages: “when delivered” and “when accepted,” creating a system to prevent incorrect materials from entering the factory.

  • Incoming Inspection System
  • Two-Step Verification System
Incoming Raw Materials

Quality Gate System

PHASEBulk Production

  • Mis-input Prevention System
  • Pharmaceutical-level Hygiene Management
Mis-input Prevention System

To prevent incorrect raw material addition, we have implemented an error-prevention system using handheld scanners. Combined with visual checks by personnel, this dual-check system ensures that the right materials in the correct quantities are added to the correct tanks

Pharmaceutical-level Hygiene Management

Lessons learned from pharmaceutical manufacturing experience have been incorporated into our quality improvement measures.

  • Mis-input Prevention System
  • Monitoring with live cameras capable of recording
  • Hygiene management based on cleaning and sterilization validation of manufacturing equipment
Bulk Production

PHASEBulk Verification

  • Bulk Testing
Bulk Testing

The quality and physical properties of the intermediate product (bulk) are inspected before filling, and only those that meet specifications proceed to the final production stage.

  • Physical Property Testing
  • Appearance and Sensory Evaluation
Bulk Verification

Quality Gate System

PHASEFilling

  • Inspection System
  • Inspection Equipment
  • Static Electricity Eliminator
Inspection System

Our factory inspection system ensures work quality by verifying that bulk materials comply with the specifications and that they have passed bulk and acceptance inspections before use.
Quality control is maintained through a double-check system that combines visual inspections with multiple camera and sensor-based checks.

Inspection Equipment

Camera inspection includes checking the lot, Camera for preventing mixing of different types (logo detection), presence of attention/virgin seal, barcode reader, etc. Sensors include height sensors (to prevent tilted caps) and metal detectors.

Static Electricity Removal Equipment

Static electricity removal equipment is installed on the filling and packaging line to prevent foreign substances and dust from adhering to containers, labels, and pumps.

  • Factory Inspection System
  • Camera for preventing mixing of different types (logo detection)
  • Static Electricity Eliminator
  • Height Sensor (Prevents Tilted Caps)
  • Metal Detector
Filling

PHASEFinished Product Inspection

  • Final Product Inspection
  • Shipment Decision
Final Product Inspection

Inspections are conducted according to standards set for each manufacturing process to maintain consistent product quality.

Shipment Decision

Shipment decisions are based on verifying production and quality records, confirming test results, reviewing any deviations and corrective actions taken, and ensuring that raw materials and products meet standards of quality, efficacy, and safety. Only products that meet these strict criteria are approved.
The pass/fail results are recorded in the product inspection system to ensure that products without shipping approval cannot be shipped.

  • Filling Quantity Check
  • Lot Number Printing Check
  • Microbiological Testing
  • Cap Torque Testing
  • Foreign Matter Check
  • Active Ingredient Analysis
Finished Product Inspection

Quality Gate System

PHASEShipping

  • Mis-shipment Prevention System
Mis-shipment Prevention System

To prevent shipping errors, a logistics system using handheld terminals has been introduced.
By scanning product QR codes, information is verified in real time, ensuring the correct product and quantity are shipped.
Furthermore, the system is designed such that products whose shipment approval has not been finalized cannot be processed, ensuring only products confirmed as “safe and secure” reach the market.

  • Product Label with QR Code
  • Mis-shipment Prevention System
Shipment

PHASESupport

  • Traceability
Traceability

Product lot samples are properly stored and utilized for quality improvement through internal knowledge sharing. This enables prompt and accurate support even after delivery, ensuring that customers can use our products with confidence.

  • Storage of Product Lot Samples
Support