Quality assurance(QA)and
Quality control(QC)
Kaneka draws on many years of experience to manufacture a diverse lineup of products in conformity to GMP.
Kaneka’s QA & QC systems and facilities are regularly inspected and improved by major pharmaceutical companies and improved through them.
In addition, we have also received approval from various governmental agencies, such as the U.S. FDA, Japanese PMDA.
Our QA & QC systems support the manufacture of API and intermediate.
Audit
| Plant | FDA audit | PMDA audit |
|---|---|---|
Kaneka Takasago |
2023, October (API) |
2016, July (API - intermediate) |
Kaneka Singapore |
2017, April (API - intermediate) |
- |
OSCL |
- |
2018, March (API) |