Production

Manufacturing, Quality Assurance, and Supply Chain

As a company dedicated to reproductive medicine—where our products come into direct contact with oocytes and embryos—Kitazato Corporation believes that quality is the essential foundation for supporting the beginning of life.

Across every process, from manufacturing and quality assurance to logistics and global distribution, we operate with deep expertise and the highest ethical standards. We are committed to fulfilling our responsibility by ensuring a stable supply of safe, high-quality products to medical institutions worldwide.

1. Quality Policy — Precision and Reliability of Made in Japan

At our primary manufacturing site in Shizuoka, production is conducted under systems compliant with international standards for medical devices and reagents. We pursue manufacturing excellence that meets the exceptionally high precision and reliability required in the field of reproductive medicine.

• Strict compliance with rigorous quality standards required for reproductive medical products
• Thorough inspection and traceability management for each individual product
• Optimal manufacturing and control systems tailored to product characteristics, including cryopreservation products, catheters, oocyte retrieval needles, and reagents
• Continuous quality improvement through process optimization

The Shizuoka plant serves as the core production base supporting our global operations and world-class quality.

2. Supply Chain Structure Supporting Stable Supply

In infertility treatment, the stable supply of products directly affects clinical outcomes.
To ensure a stable supply, we have established the following systems:

• Risk diversification through collaboration with multiple suppliers
• Improved inventory management and demand forecasting accuracy
• Strengthened international logistics through cooperation with overseas distributors
• Development of a resilient supply chain prepared for disasters and emergencies

As a company supplying products to medical institutions in more than 100 countries, we continuously work to reduce supply risks and enhance our response capabilities.

3. Reliability Assurance — Ensuring Safety, Effectiveness, and Accuracy

Kitazato Corporation has established a robust Quality Assurance (QA) system covering quality assurance, regulatory affairs, and safety information management to ensure product safety and performance.

• Strict control of manufacturing records and inspection data
• Compliance with regulatory requirements in Japan, Europe, the United States, and Asia
• Collection of safety information and usage feedback from medical institutions
• Rapid feedback and corrective actions for continuous improvement
• Accumulation and utilization of information based on scientific evidence

Given the highly specialized nature of reproductive medicine, we place a strong emphasis on balancing scientific reliability with prompt responses.

4. Advancement of Manufacturing Technology and Efficiency through DX

To meet increasing global demand and product sophistication, we continuously enhance our manufacturing technologies.

• Promotion of automation and digital monitoring of manufacturing equipment
• Utilization of digital data for production planning and quality control
• Process optimization tailored to product applications
• Standardization of work procedures and transfer of expert skills
• Strengthening production management systems in alignment with international standards

These initiatives enable rapid and stable product supply.

5. Global Compliance with International Standards

As a company delivering Japanese reproductive medical technologies to the world, Kitazato Corporation has established production and quality assurance systems compliant with regulatory requirements in each region.

• Compliance with CE, FDA, NMPA, and other international regulations
• Safety information management in cooperation with overseas subsidiaries and distributors
• Documentation systems and audit readiness aligned with international standards
• Planned expansion of production capacity to meet global market demand

Through globally trusted supply systems, we contribute to the advancement of reproductive medicine worldwide.

6. Human Resource Development — Passing on Technology and Responsibility

Manufacturing in reproductive medicine requires advanced technical skills and strong ethical awareness.
We regard human resource development as the foundation of manufacturing excellence and promote the following initiatives:

• Specialized training programs for manufacturing and inspection personnel
• Technical education tailored to product characteristics
• Strengthening team capabilities through multi-skill development
• Ethics education focused on quality and safety
• Development of professionals capable of handling international regulatory requirements

“Empowering our people to evolve our products.”
This is the fundamental philosophy underlying Kitazato Corporation’s manufacturing.