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Quality System and Management
Quality System and Management
Our group’s JP, EU, and US GMP-compliant manufacturing facilities ensure a stable supply of high-quality products by trained staff adhering to the quality policies set out in our own quality manuals.
Manufacturing Site
Manufacturer: Nippon Zenyaku Kogyo Co., Ltd. (known as ZENOAQ)*
Address: 1-1 Tairanoue, Sasagawa, Asaka-machi, Koriyama, Fukushima, Japan
Manufacturing facilities: JP, US, and EU GMP-compliant facilities
* This manufacturer and our company are sister companies.
High Quality
- WFI is used for product manufacturing
- Sterilization by filtration
- Grade-A* filling is carried out using a Restricted Access Barrier System (RABS).
(*Equivalent to US Class 100 and ISO Class 5.) - The endotoxin specification of our GMP-grade products is <0.25EU/mL, similar to WFI.
- Products undergo testing to ensure they are mycoplasma-negative.
Safety
Other Information
- Registered in FDA Bulk Biological Master File (BBMF) for GMP-grade products
- Quality questionnaires available
- Facility audits available